End Stage Kidney DiseasePhase 2/3POSIBIL6ESKDNCT05485961
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
A Phase 2/3 study testing CSL300 in people with End Stage Kidney Disease, run by CSL Behring at 566 sites in 35 countries.
Trial summary
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- CSL300
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,110 participants
- Where
- 566 sitesin 35 countries
- Study dates
- 27 Apr 2024to 22 May 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age.
- A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks.
- Serum hs-CRP ≥ 2.0 mg/L.
- A diagnosis of diabetes mellitus OR ASCVD.
Who cannot join
- Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3).
- Concomitant use of systemic immunosuppressant drugs.
- Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment.
- Abnormal LFTs.
- Any life-threatening disease expected to result in death within 12 months.
- A history of GI perforation, inflammatory bowel disease (except fully excised. ulcerative colitis), or peptic ulcer disease.
- Clinically significant active infection or history of opportunistic or invasive fungal infection.
Trial locations and contacts
566 sites in 35 countries. Contact the study team or a site near you to ask about taking part.
566 sites in 35 countries
United States167 sites, 149 recruiting
- Withdrawn
Southwest Georgia Nephrology Clinic
Albany, Georgia, 31701
- Recruiting
Albany Medical College Committee of Research Involving Human Subjects
Albany, New York, 12208
- Recruiting
Western Nephrology
Arvada, Colorado, 80002
Trial Information Contact, 303-232-3366, kmydosh@westneph.com
- Recruiting
Cussimanio Research Group LLC
Austin, Texas, 78751
Use Central Contact
- Recruiting
Research Management, Inc.
Austin, Texas, 78758
Use Central Contact
- Recruiting
National Institute of Clinical Research
Bakersfield, California, 93309
Use Central Contact
- Recruiting
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808
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- Recruiting
MW Clinical Research Center
Beaumont, Texas, 77701
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- Recruiting
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017
Use Central Contact
- Withdrawn
Amicis Research Center
Beverly Hills, California, 90211
- Recruiting
Greater Hartford Nephrology, LLC
Bloomfield, Connecticut, 06002
Use Central Contact
- Recruiting
Nephrology and Hypertension Associates
Bluefield, West Virginia, 24701
Use Central Contact
- Recruiting
- Boca Raton Regional - Research Physicians Network Alliance
Boca Raton, Florida, 33431
Use Central Contact
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Trial Information Contact, 617-724-8839, hbouchouari@mgh.harvard.edu
- Recruiting
Nova Clinical Research, LLC
Bradenton, Florida, 34209
Trial Information Contact, 941-792-6564, sade.andrews@novaclinicalresearch.com
- Completed
Southwest Mississippi Nephrology PLLC
Brookhaven, Mississippi, 39601
- Recruiting
SUNY Downstate Medical Center Brooklyn
Brooklyn, New York, 11203
- Withdrawn
Access Research Institute
Brooksville, Florida, 34613
- Recruiting
Coastal Medical Research, LLC
Brunswick, Georgia, 31520
Use Central Contact
- Recruiting
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28204
Use Central Contact
- Recruiting
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404
Trial Information Contact, 423-826-8003, dbunten@nephassociates.com
- Recruiting
DCR-Norfolk Great Bridge
Chesapeake, Virginia, 23320
Trial Information Contact, 757-636-0220, brandy.clayton@davita.com
- Recruiting
California Institute of Renal Research
Chula Vista, California, 91910
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- Recruiting
Mattoo & Bhat Medical Associates, P.C.
College Point, New York, 11356
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- Recruiting
Columbia Nephrology
Columbia, South Carolina, 29203
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- Recruiting
Renal Associates LLC
Columbus, Georgia, 31904
Use Central Contact
- Recruiting
Nephrology Associates, PC
Columbus, Mississippi, 39705
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- Recruiting
HNC Dialysis, Ltd.
Columbus, Ohio, 43215
Use Central Contact
- Withdrawn
Horizon Research Group LLC
Coral Gables, Florida, 33134
- Recruiting
South Florida Nephrology Group, PA
Coral Springs, Florida, 33071
Use Central Contact
- Recruiting
National Clinical Trials
Cordele, Georgia, 31015
- Recruiting
Dallas V.A. Medical Center
Dallas, Texas, 75216
- Recruiting
Dallas Nephrology Associates
Dallas, Texas, 75234
- Recruiting
US Renal Care
Dallas, Texas, 75237
Use Central Contact
- Recruiting
Nephrology of North Alabama
Decatur, Alabama, 35601
- Recruiting
Kidney Associates of Colorado, P.C.
Denver, Colorado, 80210
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- Recruiting
Colorado Kidney Care
Denver, Colorado, 80230
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- Recruiting
American Clinical Trials
Douglasville, Georgia, 30101
Use Central Location
- Recruiting
Durham Nephrology Associates, PA
Durham, North Carolina, 27704
Use Central Contact
- Recruiting
Duke Translational Medicine Institute
Durham, North Carolina, 27705
- Recruiting
Lifespan Clinical Research
East Providence, Rhode Island, 02915
- Recruiting
Hypertension & Nephrology Association
Eatontown, New Jersey, 07724
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- Recruiting
Davita Clinical Research
El Paso, Texas, 79925
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- Recruiting
DaVita Clinical Research - Horizon
El Paso, Texas, 79935
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- Recruiting
Clinical Renal Associates, LTD
Exton, Pennsylvania, 19341
- Recruiting
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia, 22033
Trial Information Contact, 703-961-0488 ext. 120, musirah.khan@nanvonline.com
- Recruiting
NANI Research
Fort Wayne, Indiana, 46804
Trial Information Contact
- Recruiting
Fort Worth Renal Group
Fort Worth, Texas, 76110
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- Recruiting
The Medical Research Group, Inc.
Fresno, California, 93720
- Recruiting
Davita Fullerton Dialysis Center
Fullerton, California, 92832
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- Recruiting
National Institute of Clinical Research, Inc.
Fullerton, California, 92835
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- Recruiting
U.S. Renal Care - Gallup
Gallup, New Mexico, 87301
- Recruiting
National Institute of Clinical Research, Inc.
Garden Grove, California, 92843
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- Recruiting
St. Jude Medical Center
Garden Grove, California, 92843
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- Recruiting
National Institute of Clinical Research
Garden Grove, California, 92844
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- Recruiting
AKDHC Medical
Glendale, Arizona, 85305
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- Recruiting
Kidney Disease Medical Group
Glendale, Arizona, 91206
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- Recruiting
Sherman Medical Group, Inc
Glendale, California, 91204
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- Recruiting
Kidney Disease Medical Group
Glendale, California, 91206
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- Recruiting
Renal Consultants Medical Group
Granada Hills, California, 91344
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- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Use Central Contact
- Recruiting
CN Clinical Research LLC
Greenville, South Carolina, 29605
- Recruiting
Peninsula Kidney Associates
Hampton, Virginia, 23666
Trial Information Contact, 757-637-7848, ykireeva@pen-kid.com
- Recruiting
DaVita Clinical Research - Henderson
Henderson, Nevada, 89074
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- Recruiting
Family First Medical Research Center
Hialeah Gardens, Florida, 33016
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- Recruiting
Advanced Medical Research Group
Hollywood, Florida, 33021
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- Recruiting
Royal Research, Corp
Hollywood, Florida, 33021
- Recruiting
Elixia Pines
Hollywood, Florida, 33024
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- Recruiting
Clinical Research Strategies
Houston, Texas, 77030
Trial Information Contact
- Recruiting
DaVita Clinical Research
Houston, Texas, 77054
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- Recruiting
Aqua Research Institute
Houston, Texas, 77058
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- Recruiting
Gulf Coast Clinical Research
Houston, Texas, 77070
- Recruiting
Houston Medical Research Institute, LLC
Houston, Texas, 77074
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- Recruiting
Clinical Research Strategies, Inc.
Houston, Texas, 77090
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- Recruiting
Southwest Houston Research
Houston, Texas, 77099
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- Recruiting
Nephrology Consultants, LLC
Huntsville, Alabama, 35805
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- Recruiting
New Jersey Kidney Care
Jersey City, New Jersey, 07305
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- Recruiting
Paragon Health, Inc
Kalamazoo, Michigan, 49007
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- Recruiting
Clinical Research Consultants
Kansas City, Missouri, 64111
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- Recruiting
Kansas City VA Medical Center
Kansas City, Missouri, 64128
- Recruiting
DCI-Rockhill
Kansas City, Missouri, 64131
Use Central Contact
- Withdrawn
Eastern Nephrology Associates, PLLC
Kinston, North Carolina, 28504
- Recruiting
Dialysis Clinic Inc - University Nephology
Knoxville, Tennessee, 37920
Use Central Contact
- Recruiting
Knoxville Kidney Center PLLC
Knoxville, Tennessee, 37923
Use Central Contact
- Recruiting
Balboa Research
La Jolla, California, 92037
Trial Information Contact
- Recruiting
California Institute of Renal Research
La Mesa, California, 91942
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- Recruiting
Southern California Medical Research Center
La Palma, California, 90623
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- Withdrawn
Laguna Clinical Research Associates, LLC
Laredo, Texas, 78041
- Recruiting
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89106
Use Central Contact
- Recruiting
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
Use Central Contact
- Recruiting
Georgia Nephrology
Lawrenceville, Georgia, 30046
Trial Information Contact, 404-664-7631, afelder@nephronet.com
- Recruiting
GSR Enterprises, Inc.
Lincoln, Nebraska, 68510
Use Central Contact
- Recruiting
Academic Medical Research Institute
Los Angeles, California, 90022
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- Recruiting
National Institute of Clinical Research, Inc.
Los Angeles, California, 90027
Use Central Contact
- Suspended
DaVita Carabello Dialysis Center
Los Angeles, California, 90033
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
Nephrology Associates of Kentuckiana, PSC
Louisville, Kentucky, 40205
Use Central Contact
- Recruiting
Renal Medical Associates/NARI
Lynwood, California, 90262
Use Central Contact
- Recruiting
Prime Clinical Research, Inc.
Mansfield, Texas, 76063
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- Recruiting
Gamma Medical Research, Inc.
McAllen, Texas, 78503
Use Central Location
- Recruiting
South Florida Research Organization LLC
Medley, Florida, 33166
Use Central Contact
- Recruiting
Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee, 38105
- Recruiting
Aviva Health Sciences
Miami, Florida, 33125
- Recruiting
Iconic Clinical Research Center
Miami, Florida, 33126
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- Recruiting
Total Research Group, LLC
Miami, Florida, 33126
Use Central Contact
- Withdrawn
Kidney and Hypertension Specialists of Miami
Miami, Florida, 33150
- Recruiting
Nephrology Associates of South Miami
Miami, Florida, 33173
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- Recruiting
Floridian Clinical Research
Miami Lakes, Florida, 33016
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- Recruiting
Nephrology and Hypertension Associates PC
Middlebury, Connecticut, 06762
Use Central Contact
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
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- Completed
DCR Edina
Minneapolis, Minnesota, 55404
- Recruiting
DCR Edina
Minneapolis, Minnesota, 55404
Use Central Contact
- Recruiting
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55439
- Recruiting
Nephrology Physician's LLC
Mishawaka, Indiana, 46545
Use Central Contact
- Recruiting
DaVita Clinical Research Montgomery
Montgomery, Alabama, 36117
Use Central Contact
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Withdrawn
Nephrology Associates (Delaware)
Newark, Delaware, 19713
- Recruiting
Tidewater Kidney Specialists
Norfolk, Virginia, 23502
Trial Information Contact, 757-374-7186, gladys.caro-espinal@davita.com
- Recruiting
Great Plains Health - Nephrology
North Platte, Nebraska, 69101
Use Central Contact
- Recruiting
Amicis Research Center
Northridge, California, 91324
Use Central Contact
- Withdrawn
Elixia Central Florida
Orlando, Florida, 32806
- Recruiting
FORMAT Medical Research
Oxnard, California, 93036
Use Central Contact
- Recruiting
AKDHC Medical
Phoenix, Arizona, 85018
Use Central Contact
- Recruiting
National Institute of Clinical Research, Inc.
Pomona, California, 91768
- Recruiting
Michigan Kidney Consultants, PC
Pontiac, Michigan, 48341
Use Central Contact
- Recruiting
Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire, 03801
Use Central Contact
- Recruiting
North Carolina Nephrology, PA
Raleigh, North Carolina, 27610
Use Central Location
- Recruiting
Sierra Nevada Specialty Care
Reno, Nevada, 89511
Use Central Contact
- Recruiting
Richmond V.A. Medical Center
Richmond, Virginia, 23249
- Recruiting
Van Buren Dialysis Center
Riverside, California, 92504
Use Central Contact
- Recruiting
National Nephrology Alliance Research - Riverside
Riverside, California, 92505
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- Recruiting
St. Clair Nephrology Research
Roseville, Michigan, 48066
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- Recruiting
Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan, 48081
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- Recruiting
Central Coast Nephrology Medical Corp
Salinas, California, 93901
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- Recruiting
National Institute of Clinical Research, Inc.
San Antonio, Texas, 78204
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- Recruiting
DaVita Clinical Research
San Antonio, Texas, 78229
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- Recruiting
Davita Clinical Research
San Antonio, Texas, 78251
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- Recruiting
DCR-San Antonio Stone Oak
San Antonio, Texas, 78258
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- Recruiting
California Institute of Renal Research
San Diego, California, 92111
Use Central Contact
- Suspended
California Institute of Renal Research
San Diego, California, 92123
- Recruiting
North America Research Institute
San Dimas, California, 91773
Use Central Contact
- Suspended
Satellite Healthcare
San Jose, California, 95126
- Recruiting
Infigo Clinical Research LLC
Sanford, Florida, 32771
- Recruiting
Nephrology Associates of the Carolinas
Shelby, North Carolina, 28150
- Recruiting
DaVita Clinical Research North Houston
Shenandoah, Texas, 77384
Use Central Contact
- Recruiting
Medrasa Clinical Research
Sherman, Texas, 75092
Trial Information Contact
- Recruiting
Dunes Clinical Research LLC
Sioux City, Iowa, 57049
Use Central Contact
- Recruiting
Dialysis Clinic, Inc.
Spartanburg, South Carolina, 29301
Trial Information Contact
- Recruiting
DaVita Clinical Research
Spartanburg, South Carolina, 29306
Use Central Contact
- Completed
Atekha Nephrology Clinic LLC
Statesboro, Georgia, 30458
- Suspended
Genesis Clinical Research
Tampa, Florida, 33603
- Recruiting
Nephrology Educational Services
Tarzana, California, 91356
Use Central Contact
- Recruiting
Valiance Clinical Research
Tarzana, California, 91356
Use Central Contact
- Recruiting
Florida Kidney Specialists
Temple Terrace, Florida, 33637
Use Central Contact
- Completed
DaVita Clinic Research Bronx
The Bronx, New York, 10461
- Recruiting
Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx, New York, 10467
Use Central Contact
- Recruiting
James J Peters VA Medical Center
The Bronx, New York, 10468
- Recruiting
Renal Research of Montgomery County
The Woodlands, Texas, 77384
Trial Information Contact
- Recruiting
AKDHC Medical
Tucson, Arizona, 85705
Use Central Contact
- Recruiting
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Trial Information Contact
- Recruiting
- Nephrology and Hypertension Associates Ltd
Tupelo, Mississippi, 38801
Use Central Contact
- Withdrawn
Amicis Research Center
Vacaville, California, 95687
- Recruiting
National Institute of Clinical Research, Inc
Victorville, California, 92392
Use Central Contact
- Recruiting
DaVita Vista Del Sol Dialysis
Victorville, California, 92394
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- Recruiting
Kansas Nephrology Physicians, PA
Wichita, Kansas, 67214
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- Recruiting
Florida Premier Research Institute
Winter Park, Florida, 32789
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China41 sites, 39 recruiting
- Recruiting
Inner Mongolia Baotou City Central Hospital (Baotou Central Hospital)
Baotou Shi, 14040
- Recruiting
Peking University People's Hospital
Beijeing, 100033
- Recruiting
Peking University First Hospital
Beijing, 100034
Use Central Contact
- Recruiting
China Rehabilitation Research Center (Beijing Boai Hospital)
Beijing, 100068
- Recruiting
Peking University Third Hospital
Beijing, 100191
- Recruiting
Beijing Miyun Hospital
Beijing, 101500
- Recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing, 102218
Trial Information Contact
- Recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
Chengdu, 610072
- Recruiting
The Affiliated Zhongshan Hospital (Dalian Railroad Hospital)
Dalian, 116001
- Recruiting
People's Hospital of Deyang
Deyang Shi, 618000
Trial Information Contact
- Recruiting
Dongguan People's Hospital
Dongguan, 523059
- Recruiting
The First People's Hospital - Foshan
Foshan Shi, 528000
- Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510700
- Recruiting
Anhui Medical University-The Second Hospital
Hefei, 230601
Trial Information Contact
- Recruiting
The First Hospital of Jiaxing
Jiaxing, 314001
- Recruiting
Jiangsu Province Hospital /The First Affiliated Hospital with Nanjing Medical University
Lanzhou, 210029
- Recruiting
Gansu Provincial People's Hospital
Lanzhou, 730000
Trial Information Contact
- Recruiting
Henan University of Science and Technology-The First Affiliated Hospital
Luoyang Shi, 471003
- Recruiting
The Third Hospital of Mianyang
Mianyang, 621000
- Recruiting
Nanchang University - The First Affiliated Hospital
Nanchang, 330006
Trial Information Contact
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210003
- Recruiting
Jiangsu Province Hospital of Chinese Medicine
Nanjing, 210029
- Recruiting
The People's Hospital Guangxi Zhuang of Autonomous Region
Nanning, 530021
Trial Information Contact
- Recruiting
Southern Medical University - Jiangxi Pingxiang People's Hospital
Pingxiang, 337055
Trial Information Contact
- Recruiting
Shanghai Jiao Tong University School of Medicine (SJTUSM)-Renji Hospital
Shanghai, 200001
Trial Information Contact
- Recruiting
Shanghai First People's Hospital
Shanghai Shi, 200080
Trial Information Contact
- Withdrawn
Shenzhen Second People's Hospital (Shenzhen University First Affiliated Hospital)
Shenzhen, 518035
- Recruiting
Shijiazhuang People's Hospital
Shijiazhuang, 050011
Trial Information Contact
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, 50011
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan, 030001
Trial Information Contact
- Recruiting
Tianjin People's Hospital
Tianjin, 300071
Trial Information Contact
- Recruiting
Huazhong University of Science and Technology - Tongji Medical College - The Central Hospital of Wuhan (Wuhan Second Hospital)
Wuhan, 430014
Trial Information Contact
- Recruiting
Renmin Hospital of Wuhan University/Hubei General Hospital
Wuhan, 430060
- Recruiting
Wuxi People's Hospital
Wuxi, 214023
Trial Information Contact
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, 361004
Trial Information Contact
- Recruiting
Yan'an University Xianyang Hospital
Xianyang, 712099
Trial Information Contact
- Recruiting
Xinxiang City First People's Hospital
Xinxiang, 453000
Trial Information Contact
- Withdrawn
Northern Jiangsu People's Hospital
Yangzhou, 225001
- Recruiting
Yibin Second People's Hospital
Yibin, 644000
Trial Information Contact
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
- Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001
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Japan36 sites, 34 recruiting
- Recruiting
Matsunami General Hospital
Hashima-gun, 501-6062
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- Recruiting
Ishikiriseiki Hospital
Higashiosaka-shi, 579-8026
Use Central Contact
- Recruiting
NHO Hiroshimanishi Medical Center
Hiroshima, 739-0696
- Recruiting
Miki Internal Medicine Urology Clinic
Hokkaido, 041-1121
Use Central Contact
- Recruiting
University of Tsukuba - Mito Kyodo General Hospital
Ibaraki, 310-0015
- Recruiting
Daiyukai Daiichi Hospital
Ichinomiya-shi, Aichi-ken, 491-8551
Use Central Contact
- Recruiting
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, 300-0332
Use Central Contact
- Recruiting
Ueyama Hospital
Kagoshima, 890-0073
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- Withdrawn
Ueyama Jin Clinic
Kagoshima, 890-0073
- Recruiting
Shonan Kamakura General Hospital
Kamakura-Shi, 247-8533
- Recruiting
National Hospital Organization Kanazawa Medical Center
Kanazawa, 920-8650
- Recruiting
Steel Memorial Yawata Hospital
Kitakyushu-shi, Fukuoka, 805-0050
Use Central Contact
- Recruiting
Kokura Memorial Hospital
Kitakyushu-Shi, 802-8555
- Withdrawn
Kurume University Hospital
Kurume, 830-0011
- Recruiting
St. Mary's Hospital
Kurume-shi, 830-8543
Use Central Contact
- Recruiting
Omi freai Hospital
Kusatsu-shi, Shiga, 525-8585
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- Recruiting
Rakuwakai Otowa Kinen Hospital
Kyoto, 607-8116
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- Recruiting
Maebashi Hirosegawa Clinic
Maebashi, Gunma, 371-0022
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- Recruiting
Joumou Ohashi Clinic
Maebashi, Gunma, 371-0046
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- Recruiting
Matsubara Tokushukai Hospital
Matsubara-shi, 580-0032
- Recruiting
Nagaoka Red-Cross Hospital
Nagaoka-Shi, 940-2085
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- Recruiting
Chubu Rosai Hospital
Nagoya, 455-8530
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- Recruiting
Daido Hospital
Nagoya, 457-8511
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- Recruiting
Ogaki Tokushukai Hospital
Ogaki-Shi, 503-0015
- Recruiting
Omihachiman Community Medical Center - Kidney Center
Ōmihachiman, 523-0082
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- Recruiting
Oguranaika Jin Cinic
Oyama-shi, 323-0831
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- Recruiting
Ibaraki Seinan Medical Center Hospital
Sakaimachi, 306-0433
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- Recruiting
Teine Urological Clinic
Sapporo, Hokkaido, 006-0816
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- Recruiting
Tokyo Womens Med University
Shinjuku-Ku, Tokyo, 162-8666
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- Recruiting
Kurosawa Hospital
Takasaki-Shi, 370-1203
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- Recruiting
Kikuchi Medical Clinic
Tsukuba, 305-0861
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- Recruiting
St.Hill Hospital
Ube-shi, 755-0155
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- Recruiting
Juntendo University Urayasu Hospital
Urayasu-shi, Chiba, 279-0021
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- Recruiting
Yamagata Tokushukai Hospital
Yamagata, 990-0834
- Recruiting
Bosei Kannai Clinic
Yokohama, 231-0048
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- Recruiting
Sanin Rosai Hospital
Yonago-shi, 683-8605
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Italy29 sites, 24 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, 40138
- Recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
Use Central Contact
- Recruiting
Azienda Ospedaliera Brotzu
Cagliari, 9100
- Recruiting
Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta
Caserta, 81100
Use Central Contact
- Recruiting
AOU Policlinico G Rodolico - San Marco - Presidio Ospedaliero ospedale San Marco
Catania, 95121
Trial Information Contact
- Withdrawn
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara, 44124
- Recruiting
Ospedale Santa Maria Annunziata
Florence, 50012
Use Central Contact
- Recruiting
A. O. -Universitaria Ospedali Riuniti di Foggia Farmacia Osp
Foggia, 71122
Use Central Contact
- Withdrawn
IRCCS Az. Osp. Universitaria San Martino- IST
Genova, 16132
- Withdrawn
Vito Fazzi Hospital in Lecce
Lecce, 73100
- Recruiting
ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
Lecco, 23900
Use Central Contact
- Recruiting
Università degli Studi di Messina
Messina, 98124
Use Central Contact
- Recruiting
ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
Milan, 20142
Trial Information Contact
- Withdrawn
IRCCS Ospedale San Raffaele
Milan, 20132
- Recruiting
ASST Great Metropolitan Hospital Niguarda
Milan, 20162
- Recruiting
AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
Naples, 80138
- Recruiting
Ospedale Maggiore di Novara
Novara, 28100
Use Central Contact
- Recruiting
ICS Maugeri S.p.A. SB; Università di Pavia; Fondazione Salvatore Maugeri IRCCS
Pavia, 2700
Use Central Contact
- Recruiting
University of Verona
Peschiera del Garda, 37019
Use Central Contact
- Recruiting
AUSL Piacenza Hospital-Unit Nephrology Dialysis, Dept of Medicine
Piacenza, 29121
Trial Information Contact
- Recruiting
Azienda Ospedaliero Universitaria Pisana - Ospedale di Cisanello - Stabilimento Ospedaliero di Cisanello
Pisana, 56124
- Recruiting
Ospedale Santo Stefan
Prato, 59100
Use Central Contact
- Recruiting
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, 89124
Trial Information Contact
- Recruiting
Rimini Hospital
Rimini, 47923
Use Central Contact
- Recruiting
Policlinico A. Gemelli Universitario
Roma, 168
- Withdrawn
Azienda Unita Sanitaria Locale (USL) Roma 3 (AUSL RM 3) - Presidio Ospedaliero Giovan Battista Grassi
Rome, 00122
- Recruiting
Sandro Pertini Hospital
Rome, 1577
- Recruiting
Ospedale Casa Sollievo della Sofferenza (CSS)
San Giovanni Rotondo, 71013
Use Central Contact
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
Use Central Contact
Brazil23 sites, 23 recruiting
- Recruiting
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-320
- Recruiting
NUPEC-Nucleo de Pesquisa Clinica
Belo Horizonte, 30220-140
- Recruiting
Hospital Universitário Walter Cantídio (Fortaleza)
Fortaleza, 60430-372
- Recruiting
Empresa Brasileira de Serviços Hospitalares (EBSERH)
Goiânia, 74605-020
- Recruiting
Fundacao Pro Rim de Santa Catarina
Joinville, 89227-680
- Recruiting
Clipem - Clínica o Pesquisa Endocrinológica de Maringá
Maringá, 87060-040
- Recruiting
Instituto Atena de Pesquisa Clinica
Natal, 59020500
- Recruiting
Hospital de Clinicas de Passo Fundo
Passo Fundo, 9910-260
- Recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-074
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, 90610-001
- Recruiting
CEDOES - Centro de Diagnostico e Pesquisa
Praia Do Canto, 29055-450
- Recruiting
Universidade de Sao Paulo (USP)-Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto (HCFMRP)
Ribeirão Preto, 14015-130
- Recruiting
SERVIÇO DE NEFROLOGIA DE RIBEIRÃO Preto (SENERP)
Ribeirão Preto, 14025-170
- Recruiting
Secretaria da Saúde do Estado da Bahia (SESAB)
Salvador, 40321-210
- Recruiting
Clinica Senhor do Bonfim Ltda (CSB) - Monte Serrat
Salvador, 40415-065
- Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 01246-903
- Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-020
- Recruiting
Hospital do Rim e Hipertensão
São Paulo, 04024-002
- Recruiting
Trialstar-Centro de Pesquisa Clinicas
São Paulo, 05690040-903
- Recruiting
Hospital Santa Marcelina
São Paulo, 08270-070
- Recruiting
Hospital 9 de Julho
São Paulo, 1409-902
Spain21 sites, 19 recruiting
- Recruiting
Centro de dialisis Alcobendas
Alcobendas, 28100
- Recruiting
Hospital Universitari de Bellvitge (IDIBELL)
Barcelona, 08907
- Recruiting
Hospital Universitario Valle de Hebron
Barcelona, 8035
- Recruiting
University Hospital Reina Sofía
Córdoba, 14005
- Recruiting
Hospital Universitari de Girona Dr Josep Trueta, (Avitum)
Girona, 17007
Trial Information Contact
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
- Withdrawn
Universidad de Alcala (UAH)
Guadalajara, 19002
- Recruiting
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Use Central Contact
- Recruiting
Hospital Universitario de La Princesa
Madrid, 28006
- Recruiting
Universitario Gregorio Marañón
Madrid, 28007
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario Príncipe de Asturias
Madrid, 28806
- Recruiting
Hospital de Manises
Manises, 46940
Trial Information Contact
- Recruiting
Hospital Universitari Son Espases
Palma de Mallorca, 7120
- Recruiting
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, 15706
- Recruiting
Hospital Universitario Virgen de la Macarena
Seville, 41009
- Withdrawn
Fresenius Medical Care Centro de Diálisis Terrassa
Terrassa, 8223
- Recruiting
Hospital Clinico Universitario - Valencia
Valencia, 46010
Trial Information Contact
- Recruiting
Centro Hospital Universitario Dr. Preset
Valencia, 46017
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Trial Information Contact
Australia18 sites, 15 recruiting
- Withdrawn
Wide Bay Hospital and Health Service
Bundaberg, 4670
- Recruiting
Cairns Hospital
Cairns, Queensland, 4870
Use Central Contact
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
Use Central Contact
- Recruiting
Austin Hospital
Heidelberg, 3084
Trial Information Contact
- Recruiting
Liverpool Hospital
Liverpool, 2170
- Recruiting
Fiona Stanley Hospital
Murdoch, 6150
Use Central Contact
- Suspended
Sunshine Coast University Private Hospital
Nambour, Queensland, 4560
- Recruiting
Sunshine Coast University Private Hospital
Nambour, 4560
Use Central Contact
- Recruiting
Royal Melbourne Hospital
Parkville, 3052
Trial Information Contact
- Recruiting
Royal North Shore Hospital (RNSH)
Saint Leonards, New South Wales, 2065
Use Central Contact
- Recruiting
Gold Coast University Hospital
Southport, 4215
Use Central Contact
- Recruiting
Sunshine Hospital
St Albans, Victoria, 3021
Use Central Contact
- Recruiting
Concord Repatriation General Hospital
Sydney, New South Wales, 2139
Use Central Contact
- Recruiting
Fraser Coast Renal Service, Hervey Bay Hospital
Urraween, 4655
Trial Information Contact
- Recruiting
Sydney Adventist Hospital
Wahroonga, 2076
Trial Information Contact
- Recruiting
Westmead Hospital
Westmead, 2145
Use Central Contact
- Recruiting
Wollongong Renal Unit
Wollongong, 2500
Use Central Contact
- Suspended
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
France18 sites, 14 recruiting
- Recruiting
CHU Amiens - Nephrology Dialysi Transplantation Department
Amiens, 80054
Use Central Contact
- Recruiting
CHU de Saint-Étienne - Hôpital Nord
Aura, 42055
Use Central Contact
- Withdrawn
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche
Brest, 29200
- Withdrawn
CHU de Caen
Caen, 14000
- Recruiting
Polyclinique Saint Come - Centre de Dialyse
Compiègne, 60200
- Recruiting
Fondation Charles Mion AIDER Santé
Grabels, 34790
Trial Information Contact
- Withdrawn
Hopital Prive La Louviere
Lille, 59000
- Recruiting
CHU de Limoges
Limoges, 87042
Use Central Contact
- Withdrawn
Hopitaux Universitaires de Marseille
Marseille, 13005
- Recruiting
Centre Hospitalier Universitaire Montpellier - Hôpital Lapeyronie
Montpellier, 34295
Use Central Contact
- Recruiting
CHE de Nice - Pasteur Hospital
Nice, 6000
- Recruiting
CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, 30029
Trial Information Contact
- Recruiting
Hopital Pitie-Salpetriere
Paris, 75013
Trial Information Contact
- Recruiting
AURA Paris - Plaisance
Paris, 75014
Use Central Contact
- Recruiting
Centre Hospitalier Universitaire (CHU) de Reims - Hopital Maison Blanche
Reims, 51092
Trial Information Contact
- Recruiting
AURA St Quen Dialysis centre
Saint-Ouen, 93400
Use Central Contact
- Recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg, 67091
Use Central Contact
- Recruiting
CHU Rangueil
Toulouse, 31059
use Central Contact
Romania18 sites, 17 recruiting
- Recruiting
Centrul de Dializa Fresenius NephroCare Brasov
Brasov, 500152
- Withdrawn
Institutul National de Diabet, Nutriţie şi Boli Metabolice - Prof. Dr. N. Paulescu - Central
Bucharest, 020475
- Recruiting
SC International Healthcare Systems SA - IHS Sf. Ioan Dialysis Center
Bucharest, 042122
Use Central Contact
- Recruiting
Centrul De Nefrologie si Dializa DIAVERUM SPLAI
Bucharest, 060044
- Recruiting
Centrul de Dializa Fresenius NephroCare Bucaresti
Bucharest, 203512
- Recruiting
Fundeni Clinical Institute
Bucharest, 22328
Use Central Contact
- Recruiting
Centrul de Nefrologie si Dializa DIAVERUM Sema Parc
Bucharest, 60044
- Recruiting
Centrul de Nefrologie si Dializa Diaverum Fundeni
Bucharest, 77085
- Recruiting
Centrul de Dializa Fresenius NephroCare Cluj
Cluj-Napoca, 400505
- Recruiting
Centrul de Dializa Fresenius NephroCare Constanta
Constanța, 900001
- Recruiting
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta (Emergency Clinic Hospital Constanta)
Constanța, 900591
Use Central Contact
- Recruiting
Centrul de Nefrologie si Dializa Diaverum Craiova
Craiova, 200349
- Recruiting
Spitalul Judetean de Urgenta Deva
Deva, 33081
- Recruiting
Spitalul Clinic -Dr. C.I. Parhon - Iasi
Iași, 700503
Trial Information Contact
- Recruiting
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea
Oradea, 410057
- Recruiting
Centrul de Dializa Fresenius NephroCare Ploiesti
Ploieşti, 100551
- Recruiting
Spital Judetean de Urgenta Satu Mare
Satu Mare, 440055
Use Central Contact
- Recruiting
Centrul Medical de Nefrologie si Dializa Diaverum Targu Mures
Târgu Mureş, 540487
Argentina16 sites, 16 recruiting
- Recruiting
FME Lomas de Zamora
Banfield, 1828
- Recruiting
FME Mansilla
Buenos Aires, 1425
- Recruiting
Instituto de Trasplante De La Ciudad Autonoma De Buenos Aires
Buenos Aires, 6022
- Recruiting
FME Avellaneda
Buenos Aires, B1870ARU
- Recruiting
FME Cemic Saavedra
Ciudad Autonoma, C1431FWO
- Recruiting
CEREHA
Ciudad de Buenos Aires, C1426
- Recruiting
Fresenius Medical Care - Ciudad Evita
Ciudad Evita, B1778IFA
- Recruiting
Clinica Privada Velez Sarsfield
Córdoba, 5016
- Recruiting
FME Formosa
Formosa, 3600
- Recruiting
STR Hurlingham SRL
Hurlingham, B 1686
- Recruiting
Nextdial S.A.
Mar del Plata, 7600
- Recruiting
Fresenius Medical Care - Nostri Centri Dialisi - Moron
Morón, B1708DPO
- Recruiting
Instituto Medico de la Fundacion de Estudios Clínicos
Rosario, S2000DEJ
- Recruiting
FME San Fernando
San Fernando, 1646
- Recruiting
Fresenius Tucumán
San Miguel de Tucumán, 4000
- Recruiting
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe, S3000BPJ
Canada16 sites, 15 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G2P4
Use Central Contact
- Recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A6
Trial Information Contact, 1-902-473-7625, laura.sills@nshealth.ca
- Recruiting
St. Josephs Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Use Central Contact
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Trial Information Contact, 1-613-533-6000, muhammed.zaman@queensu.ca
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
Use Central Contact
- Withdrawn
Hospital Charles Lemoyne
Longueuil, J4V 2H1
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Use Central Contact
- Recruiting
Hôpital du Sacré-Cœur-de-Montréal
Montreal, Quebec, H4J 1C5
Trial Information Contact, 1-514-338-2222 ext. 1-3182, guylaine.marcotte.cnmtl@ssss.gouv.qc.ca
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal, H1T 2M4
Trial Information Contact, 1-514-252-3400 ext. 3722, karine.chausse.cemtl@ssss.gouv.qc.ca
- Recruiting
CHUM - Centre hospitalier de l'Universite de Montreal
Montreal, H2X 3E4
Use Central Contact
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Use Central Contact
- Recruiting
The Ottawa Hospital Research Institute
Ottawa, K1H 8L6
- Recruiting
Ciussse-Chus
Sherbrooke, J1H 5N4
Trial Information Contact
- Recruiting
St. Michaels Hospital
Toronto, M5B 1W8
Use Central Contact
- Recruiting
St Paul Hospital
Vancouver, V6Z 1Y6
Trial Information Contact
- Recruiting
Seven Oaks Hospital
Winnipeg, R2V 3M3
Trial Information Contact
Greece16 sites, 15 recruiting
- Recruiting
University Hospital of Alexandroupolis
Alexandroupoli, 68100
Use Central Contact
- Withdrawn
General Hospital of Arta
Arta, 471 00
- Recruiting
Korgialenio-Benakio Hellenic Red Cross Hospital
Athens, 115 26
- Recruiting
University General Hospital of Heraklion
Crete, 71500
Use Central Contact
- Recruiting
Mesogeios Nephrology Center
Haidari, 12461
- Recruiting
University General Hospital of Ioannina
Ioannina, 45110
Use Central Contact
- Recruiting
General Hospital of Ioannina G. Hatzikosta
Ioannina, 45445
Use Central Contact
- Recruiting
Nephrological Clinic University Hospital, University of Thessaly
Larissa, 41110
Use Central Contact
- Recruiting
Mitera Hospital, Hemodialysis Unit
Marousi, 15123
- Recruiting
General Hospital of Ptolemaida
Ptolemaida, 50200
Trial Information Contact
- Recruiting
University Hospital of Patras
Rio, 265 04
Use Central Contact
- Recruiting
AHEPA Univ. Hospital, Medical School, Aristotle University of Thessaloniki
Thessaloniki, 45500
Use Central Contact
- Recruiting
Aristotle University, Hippokration
Thessaloniki, 54642
Use Central Contact
- Recruiting
General Hospital of Thessaloniki, Agios Pavlos
Thessaloniki, 55134
Use Central Contact
- Recruiting
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56403
Use Central Contact
- Recruiting
Nephrology Department G. Papanikolaou General Hospital
Thessaloniki, 570 10
Use Central Contact
United Kingdom15 sites, 13 recruiting
- Withdrawn
University Hospitals Birmingham NHS Foundation Trust - Birmingham Heartlands Hospital (BHH)
Birmingham, B9 5SS
- Recruiting
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
Use Central Contact
- Recruiting
University Hospital Coventry and Warwickshire
Coventry, CV2 2DX
Use Central Contact
- Recruiting
University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
Derby, DE22 3NE
Use Central Contact
- Withdrawn
Dorset County Hospital NHS Foundation Trust - Dorset County Hospital (DCH)
Dorchester, DT1 2JY
- Recruiting
Royal Liverpool University Hospital
Liverpool, L7 8XP
Use Central Contact
- Recruiting
William Harvey Research Institute ; Barts Health NHS Trust - The Royal London Hospital
London, E1 1BB
Trial Information Contact
- Recruiting
King´s College NHS Trust
London, SE5 9RS
Trial Information Contact
- Recruiting
St George's University Hospitals NHS Foundation Trust - St G
London, SW17 0QT
Use Central Contact
- Recruiting
Hammersmith Hospital Imperial College Healthcare NHS Trust -Hammersmith Hospital - West London Renal and Transplant Centre
London, W12 0HS
Trial Information Contact
- Recruiting
Altnagelvin Area Hospital
Londonderry, BT47 6SB
Use Central Contact
- Recruiting
Northern Care Alliance NHS Foundation Trust - Salford Royal NHS Foundation Trust-Salford Care Organisation
Salford, M6 8HD
Use Central Contact
- Recruiting
The Shrewsbury and Telford Hospital NHS Trust (SaTH) - Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
Trial Information Contact
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Use Central Contact
- Recruiting
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton, WV10 0QP
Use Central Contact
Poland13 sites, 11 recruiting
- Recruiting
Davita Stacja Dializ w Brodnicy
Brodnica, 87-300
- Recruiting
Slaski Uniwersytet Medyczny (SUM) w Katowicach
Katowice, 40-027
- Recruiting
Davita-Łęczna
Łęczna, 21-010
- Recruiting
Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego
Lodz, 90-153
- Recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodz, Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek
Lodz, 92-213
- Withdrawn
Davita- Naklo n. Notecią
Naklo N. Notecią, 89-100
- Recruiting
DaVita Stacja Dializ
Pszczyna, 43-200
- Recruiting
Powiatowy Szpital Specjalistyczny w Stalowej Woli
Stalowa Wola, 37-450
Trial Information Contact
- Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr. 2 Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, 70-111
- Recruiting
Diaverum - NZOZ Tczewie
Tczew, 83-110
Trial Information Contact
- Recruiting
DaVita Stacja Dializ
Warsaw, 01-211
Trial Information Contact
- Withdrawn
Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii, CSK MSWiA
Warsaw, 02-507
- Recruiting
Wojskowy Instytut Medyczny (WIM) - Centralny Szpital Kliniczny (CSK) MON - Klinika Chorob Wewnetrznych
Warsaw, 04-349
Bulgaria12 sites, 12 recruiting
- Recruiting
Multiprofile Hospital for Active Treatment - Dobrich AD
Dobrich, 9300
- Recruiting
Multiprofile Hospital For Active Treatment Dr Tota Venkova
Gabrovo, 5300
Trial Information Contact
- Recruiting
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
Lom, 3600
Use Central Contact
- Recruiting
Dialysis Centre Montana
Montana, 3400
- Recruiting
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002
Trial Information Contact
- Recruiting
UMHAT Plovdiv
Plovdiv, 4003
Trial Information Contact
- Recruiting
Multiprofile Hospital for Active Treatment Dr. Ivan Seliminski - Sliven AD
Sliven, 6600
Trial Information Contact
- Recruiting
Medical Center - Smolyan OOD
Smolyan, 4700
Use Central Contact
- Recruiting
UMHAT Aleksandrovska
Sofia, 1432
- Recruiting
University Hospital for Active Treatment Tsaritsa Joanna ISUL EAD
Sofia, 1527
- Recruiting
Dialysis Center VIA DIAL OOD
Stara Zagora, 6000
Use Central Contact
- Recruiting
UMHAT Prof. Dr. Stoyan Kirkovich
Stara Zagora, 6000
Trial Information Contact
Portugal12 sites, 12 recruiting
- Recruiting
Unidade Local de Saúde de Braga, E. P. E.
Braga, 4710-243
Use Central Contact
- Recruiting
Caledial - Centro de Hemodiálise de Gaia
Canelas-V.N.Gaia, 4410-313
- Recruiting
NephroCare Carregado
Carregado, 2580-588
- Recruiting
Nephrocare Faro
Faro, 8055-546
- Recruiting
Centro Hospitalar e Universitário de Lisboa Centra
Lisbon, 1050-099
- Recruiting
Fresenius Medical Care - NephroCare - Unidade de Hemodialise do Restelo
Lisbon, 1400-195
- Recruiting
Unidade Local de Saúde de Loures -Odivelas, E. P. E.
Loures, 2674-514
Use Central Contact
- Recruiting
Unidade Local de Saúde de São José, E. P. E.
Oeiras, 2790
Use Central Contact
- Recruiting
Unidade Local de Saúde de Santo António, E. P. E.
Porto, 4099-001
Use Central Contact
- Recruiting
Fresenius NephroCare
Porto, 4470-235
- Recruiting
Unidade Local de Saúde do Médio Tejo, E. P. E.
Torres Novas, 2354-754
- Recruiting
Unidade Local de Saúde do Estuário do Tejo, E. P. E.
Vila Franca de Xira, 2600-009
Trial Information Contact
Israel11 sites, 10 recruiting
- Withdrawn
Emek Medical Center
Afula, 18105
- Recruiting
Barzilai Medical Center
Ashkelon, 7830604
- Recruiting
Carmel Medical Center
Haifa, 3436212
Use Central Contact
- Recruiting
Edith Wolfson Medical Center
Holon, 58100
Use Central Contact
- Recruiting
Galilee Medical Center
Nahariya, 2244624
- Recruiting
Rabin Medical Center
Petah Tikva, 4941492
Use Central Contact
- Recruiting
Chaim Sheba Medical Center (Sheba Tel-Hashomer Medical Center )
Ramat Gan, 3109601
Use Central Contact
- Recruiting
Kaplan Medical Center
Rehovot, 7661041
- Recruiting
Ziv Medical Center
Safed, 13110
Use Central Contact
- Recruiting
Ichilov Hospital-Tel-Aviv Sourasky Medical Center
Tel Aviv, 84100
Use Central Contact
- Recruiting
Medical Research & Development Fund for Health Services, PORIYA Hospital
Tiberias, 15208
Use Central Contact
Belgium10 sites, 9 recruiting
- Recruiting
Onze-Lieve-Vrouwziekenhuis VZW
Aalst, 9300
Use Central Contact
- Recruiting
Imelda Ziekenhuis
Bonheiden, 2820
Use Central Contact
- Recruiting
Centre Hospitalier Universitaire (CHU) de Charleroi - Hopital Civil Marie Curie
Charleroi, 6042
- Suspended
AZ Sint-Lucas
Ghent, 9000
- Recruiting
Centre Hospitalier Universitaire de Tivoli
La Louvière, 7100
Use Central Contact
- Recruiting
Jan Yperman Ziekenhuis
Leper, 8900
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
Use Central Contact
- Recruiting
CHR de la Citadelle
Liège, 4000
Use Central Contact
- Recruiting
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
Roeselare, 8800
Use Central Contact
- Recruiting
VITAZ, Department Nierziekten & Dialyse
Sint-Niklaas, 9100
Trial Information Contact
South Korea10 sites, 6 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, 14068
Use Central Contact
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, 42601
Use Central Contact
- Recruiting
Gangnam Severance Hospital
Gangnam-gu, 6273
Use Central Contact
- Withdrawn
National Health Insurance Service - Ilsan Hospital
Goyang-si, 10444
- Recruiting
Hanyang University Guri Hospital
Guri-si, 11923
Trial Information Contact
- Recruiting
Konkuk University Medical Center
Gwangju, 5030
Use Central Contact
- Recruiting
SMG - SNU Boramae Medical Center
Ilsan-gu, Seoul, 7061
Use Central Contact
- Withdrawn
Seoul National University Hospital
Seoul, 03080
- Withdrawn
Severance Hospital, Yonsei University
Seoul, 03722
- Withdrawn
Yonsei University - Wonju Severance Christian Hospital
Wŏnju, 26426
Turkey (Türkiye)10 sites, 10 recruiting
- Recruiting
Hacettepe University,Faculty of Medicine
Ankara, 6230
- Recruiting
Akdeniz University Medical Faculty Hospital
Antalya, 7070
- Recruiting
Ondokuz Mayis Üniversitesi
Atakum, 55280
- Recruiting
İstanbul Bakirköy Dr.Sadi Konuk Eğitim Araştirma Hastanesi
Bakırköy, 34147
- Recruiting
Ege University Hospital
Bornova, 35100
- Recruiting
Trakya Üniversitesi Tıp Fakültesi
Edirne, 22030
- Recruiting
Gaziantep University
Gaziantep, 27310
- Recruiting
Kocaeli University, Medical Faculty, Division of Nephrology
İzmit, 41000
- Recruiting
Kahramanmaras Sutcu Imam University - Tip Fakultesi (Kahramanmaras Sutcu Imam University Faculty of Medicine)
Kahramanmaraş, 46040
- Recruiting
Malatya Education and Research Hospital
Yeşilyurt, 44000
Germany7 sites, 5 recruiting
- Recruiting
Charite-Universitatsmedizin Berlin
Berlin, 13353
Use Central Contact
- Recruiting
Nierenzentrum Bad König
Hessen, 64732
Use Central Contact
- Recruiting
Westpfalz Klinikum GmbH
Kaiserslautern, 67655
Use Central Contact
- Suspended
UKSH - Universitatsklinik Schleswig-Holstein
Kiel, 24105
- Recruiting
Kuratorium fuer Dialyse und Nierentransplantation e.V. - KfH-Nierenzentrum - St. Georg
Leipzig, 04129
Trial Information Contact
- Withdrawn
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
- Recruiting
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, 78052
Use Central Contact
Taiwan7 sites, 7 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, 330006
- Recruiting
The First People's Hospital of Nanning
Nanning Shi, 530022
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220216
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235041
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Recruiting
Taipei Medical University - Taipei Medical University Hospital
Taipei, 110
Malaysia6 sites, 6 recruiting
- Recruiting
Hospital Raja Permaisuri Bainun, Ipoh
Ipoh, 31400
- Recruiting
Queen Elizabeth Hospital
Kota Kinabalu, 88300
- Recruiting
University Malaya Medical Centre
Lembah Pantai, 59100
- Recruiting
Hospital Kuala Lumpur
Pejabat Pakar, 50586
- Recruiting
Seberang Jaya Hospital
Perai, 13700
- Recruiting
Seri Manjung Hospital
Perak, 32040
Czechia5 sites, 5 recruiting
- Recruiting
Interni Oddeleni Nemocnice
Český Krumlov, 381 01
- Recruiting
Fakultni Nemocnice Hradec Kralove (FNHK) - Hemodialyzacni Stredisko (HDS)
Hradec Králové, 500 05
- Recruiting
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, 741 01
- Recruiting
Fakultní Nemocnice Ostrava (FNO) - Interni Klinika
Ostrava, 708 00
- Recruiting
Fakultní nemocnice Královské Vinohrady
Prague, 100 34
Denmark5 sites, 4 recruiting
- Recruiting
Aalborg Universitetshospital
Aalborg, 9000
Use Central Contact
- Recruiting
Herlev Hospital
Herlev, 2730
Use Central Contact
- Recruiting
Gødstrup Hospital
Herning, 7400
Use Central Contact
- Recruiting
Trail Nation: Nordsjællands Hospital
Hillerød, 3400
Use Central Contact
- Withdrawn
Holbæk Sygehus
Holbæk, 4300
Hong Kong3 sites, 3 recruiting
- Recruiting
Princess Margaret Hospital
Ho Man Tin, 999077
- Recruiting
Queen Mary Hospital Hong Kong
Pok Fu Lam, 852
- Recruiting
Yan Chai Hospital
Tsuen Wan, 999077
Netherlands3 sites, 3 recruiting
- Recruiting
Gelre Ziekenhuizen
Apeldoorn, 7334 DZ
- Recruiting
Catharina hospital
Eindhoven, 5623 EJ
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam, 3045PM
Norway3 sites, 3 recruiting
- Recruiting
Vestre Viken HF - Drammen Sykehus (Sykehuset Buskerud)
Drammen, 3004
Trial Information Contact
- Recruiting
Sykehuset Østfold Kalnes
Grålum, 1714
- Recruiting
Sykehuset Telemark
Skien, 3710
Slovakia3 sites, 3 recruiting
- Recruiting
Nefrologicka ambulancia Levice - FMC dialyzacne sluzby, s.r.o.
Levice, 934 01
- Recruiting
LC-REN s.r.o.
Lučenec, 98401
Trial Information Contact
- Recruiting
Biodial, s.r.o.
Púchov, 020 01
Sweden3 sites, 3 recruiting
- Recruiting
Karolinska Huddinge
Huddinge, 14186
- Recruiting
Region Stockholm-SLSO
Stockholm, 113 65
- Recruiting
Uppsala Universitet - Akademiska Sjukhuset
Uppsala, 75185
Use Central Contact
Thailand3 sites, 3 recruiting
- Recruiting
Maharat Nakhon Ratchasima Hospital
Amphoe Mueang, 30000
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
- Recruiting
Chiang Mai University
Chiang Mai, 50200
Hungary2 sites, 1 recruiting
- Withdrawn
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
- Recruiting
B. Braun Avitum - 14. Dialízisközpont Kistarcs
Kistarcsa, 2143
Use Central Contact
Mexico2 sites, 2 recruiting
- Recruiting
Medica Santa Carmen
Mexico City, 4739
- Recruiting
Servicios de Oncologia Medica SA de CV (Renal Center)
Monterrey, 64040
Austria1 site, 1 recruiting
- Recruiting
Wiener Gesundheitsverbund - Klinik Hietzing
Vienna, 1130
Trial Information Contact
Puerto Rico1 site, 1 recruiting
- Recruiting
Legacy Senior Living
Humacao, 791
About this study
Official title: A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study.
Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
- Conditions
- End Stage Kidney Disease
- Being tested
- CSL300, Placebo
- Keywords
- End Stage Kidney Disease (ESKD), Myocardial infarction (MI), Atherosclerotic cardiovascular disease (ASCVD), Coronary artery disease, Peripheral artery disease, Diabetes
- Medical subject headings
- Kidney Failure, Chronic, Myocardial Infarction, Atherosclerosis, Coronary Artery Disease, Peripheral Arterial Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL300Drug
Also called Clazakizumab
IV administration
PlaceboDrug
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| CSL300 (low dose)(Phase 2b) | Experimental | Intravenous (IV) administration Receives: Drug: CSL300 |
| CSL300 (medium dose)(Phase 2b) | Experimental | IV administration Receives: Drug: CSL300 |
| CSL300 (high dose)(Phase 2b) | Experimental | IV administration Receives: Drug: CSL300 |
| Placebo (Phase 2b) | Placebo comparator | IV administration Receives: Drug: Placebo |
| CSL300 (Phase 3) | Experimental | IV administration Receives: Drug: CSL300 |
| Placebo (Phase 3) | Placebo comparator | IV administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Measured: Baseline and up to Week 12
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
Measured: Approximately 5 years
Secondary outcomes (38)
Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)
Measured: Week 12
Change from baseline in log-transformed hs-CRP (Phase 2b)
Measured: Baseline and up to Week 24
Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in fibrinogen (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in albumin (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in Hepcidin (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in hemoglobin (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in iron (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)
Measured: Baseline and up to Week 12
Mean change from Baseline in ferritin (Phase 2b)
Measured: Baseline and up to Week 12
Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)
Measured: Up to Week 24
Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)
Measured: Up to Week 24
Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)
Measured: Up to Week 24
Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)
Measured: Up to Week 24
Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)
Measured: Up to Week 32
Mean change from Baseline in white blood cell (WBC) (Phase 2b)
Measured: Up to Week 12
Mean change from Baseline in neutrophils (Phase 2b)
Measured: Up to Week 12
Mean change from Baseline in platelets (Phase 2b)
Measured: Up to Week 12
Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)
Measured: Up to Week 12
Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)
Measured: Up to Week 12
Mean change from Baseline in total bilirubin (Phase 2b)
Measured: Up to Week 12
Mean change from Baseline in lipid panel (Phase 2b)
Lipid panel consists of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride.
Measured: Up to Week 12
Titer of confirmed antibodies specific to CSL300 (Phase 2b)
Measured: Up to Week 12
Time to first occurrence of all-cause death or MI (Phase 3)
Measured: Approximately 5 years
Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)
Measured: Approximately 5 years
Time to first occurrence of CV death (Phase 3)
Measured: Approximately 5 years
Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)
Measured: Approximately 5 years
Time to first occurrence of all-cause death (Phase 3)
Measured: Approximately 5 years
Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)
Measured: Up to 5 years
Total number of CV hospitalizations (Phase 3)
Measured: Approximately 5 years
Total number of HF hospitalizations and urgent visits (Phase 3)
Measured: Approximately 5 years
Total number of hospitalizations (Phase 3)
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start27 Apr 2024
- Primary completion22 May 2029 (estimated)
- Study completion22 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485961
- Sponsor's protocol ID
- CSL300_2301
- Other IDs
- 2022-500273-14-00
- Acronym
- POSIBIL6ESKD
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Publications
Chertow GM, Chang AM, Felker GM, Heise M, Velkoska E, Fellstrom B, Charytan DM, Clementi R, Gibson CM, Goodman SG, Jardine M, Levin A, Lokhnygina Y, Mears J, Mehran R, Stenvinkel P, Wang AY, Wheeler DC, Zoccali C, Ridker PM, Mahaffey KW, Tricoci P, Wolf M. IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial. Nat Med. 2024 Aug;30(8):2328-2336. doi: 10.1038/s41591-024-03043-1. Epub 2024 May 25.
PubMed 38796655
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis
- ClinicalTrials.gov ID
- NCT05485961
- Acronym / sponsor ID
- POSIBIL6ESKD / CSL300_2301
- Conditions
- End Stage Kidney Disease
- Keywords
- End Stage Kidney Disease (ESKD), Myocardial infarction (MI), Atherosclerotic cardiovascular disease (ASCVD), Coronary artery disease, Peripheral artery disease, Diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,110 participants (estimated)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 22 May 2029 (estimated)
- Study completion
- 22 May 2029 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study.
Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CSL300 (low dose)(Phase 2b) | Experimental | Drug: CSL300Intravenous (IV) administration |
| CSL300 (medium dose)(Phase 2b) | Experimental | Drug: CSL300IV administration |
| CSL300 (high dose)(Phase 2b) | Experimental | Drug: CSL300IV administration |
| Placebo (Phase 2b) | Placebo comparator | Drug: PlaceboIV administration |
| CSL300 (Phase 3) | Experimental | Drug: CSL300IV administration |
| Placebo (Phase 3) | Placebo comparator | Drug: PlaceboIV administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at least 18 years of age.
- A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks.
- Serum hs-CRP ≥ 2.0 mg/L.
- A diagnosis of diabetes mellitus OR ASCVD.
Key exclusion criteria (7 listed)
- Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3).
- Concomitant use of systemic immunosuppressant drugs.
- Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment.
- Abnormal LFTs.
- Any life-threatening disease expected to result in death within 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSL300Also: ClazakizumabIV administration | Drug | CSL300 (Phase 3), CSL300 (high dose)(Phase 2b), CSL300 (low dose)(Phase 2b), CSL300 (medium dose)(Phase 2b) |
| PlaceboMatching the excipient content and concentration of the CSL300 product, minus the active ingredient. | Drug | Placebo (Phase 2b), Placebo (Phase 3) |
Primary outcome
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Time frame: Baseline and up to Week 12
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
Time frame: Approximately 5 years
38 secondary outcomes
Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)
Time frame: Week 12
Change from baseline in log-transformed hs-CRP (Phase 2b)
Time frame: Baseline and up to Week 24
Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in fibrinogen (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in albumin (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in Hepcidin (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in hemoglobin (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in iron (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in ferritin (Phase 2b)
Time frame: Baseline and up to Week 12
Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)
Time frame: Up to Week 24
Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)
Time frame: Up to Week 24
Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)
Time frame: Up to Week 24
Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)
Time frame: Up to Week 24
Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)
Time frame: Up to Week 32
Mean change from Baseline in white blood cell (WBC) (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in neutrophils (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in platelets (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in total bilirubin (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in lipid panel (Phase 2b)
Time frame: Up to Week 12
Titer of confirmed antibodies specific to CSL300 (Phase 2b)
Time frame: Up to Week 12
Time to first occurrence of all-cause death or MI (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of CV death (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of all-cause death (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)
Time frame: Up to 5 years
Total number of CV hospitalizations (Phase 3)
Time frame: Approximately 5 years
Total number of HF hospitalizations and urgent visits (Phase 3)
Time frame: Approximately 5 years
Total number of hospitalizations (Phase 3)
Time frame: Approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 38796655Chertow GM, Chang AM, Felker GM, Heise M, Velkoska E, Fellstrom B, Charytan DM, Clementi R, Gibson CM, Goodman SG, Jardine M, Levin A, Lokhnygina Y, Mears J, Mehran R, Stenvinkel P, Wang AY, Wheeler DC, Zoccali C, Ridker PM, Mahaffey KW, Tricoci P, Wolf M. IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial. Nat Med. 2024 Aug;30(8):2328-2336. doi: 10.1038/s41591-024-03043-1. Epub 2024 May 25.
- Individual participant dataSharing planned: Yes. CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
CSL Behring LLC
566 sites in 35 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CSL300 in people with End Stage Kidney Disease, run by CSL Behring at 566 sites in 35 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 566 sites in United States, China, Japan, Italy, Brazil and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Registration Coordinator (+1 610-878-4697, clinicaltrials@cslbehring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b) (time frame: Baseline and up to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.