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HyperphosphatemiaNCT00567723

Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)

An observational study of Hyperphosphatemia, run by Shire at 199 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperphosphatemia
How many people
2,105 participants
Where
199 sitesUnited States
Study dates
25 Apr 2006to 7 Jun 2016
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Patients for the Historical Control and Concomitant Therapy Groups will be selected from the United States Renal Data System (USRDS). The Test Group will consist of patients who have had a minimum of 12 consecutive weeks of exposure to Fosrenol (lanthanum carbonate).

Who may be able to join

  • Signed informed consent
  • Patient must have ESRD and be receiving dialysis
  • Prior treatment with Fosrenol for a minimum of 12 consecutive weeks
  • Primary payer of healthcare must be Medicare (patient must supply Medicare Claim Number)
  • Patient must be 18 years of age or older

Who cannot join

  • Patients that do not meet inclusion criteria

Trial locations and contacts

199 sites in 1 country.

199 sites in 1 country

United States199 sites

  • Great Lakes Renal Network

    Alma, Michigan, 48801

  • Nephrology and Internal Medicine

    Anderson, South Carolina, 29621

  • Fox Valley Nephrology Partners, SC

    Appleton, Wisconsin, 54911

  • Arlington Nephrology, PA

    Arlington, Texas, 76015

  • Mountain Kidney

    Asheville, North Carolina, 28801

  • North Georgia Nephrology Consultant

    Athens, Georgia, 30606

  • Southwest Atlanta Nephrology, PC

    Atlanta, Georgia, 30331

  • North Atlantic Kidney Specialist

    Atlanta, Georgia, 30342

  • AtlantaDavita East

    Atlanta, Georgia

  • Davita South Fulton

    Atlanta, Georgia

  • Kidney Care Associates, LLC

    Augusta, Georgia, 30901

  • Fox Valley Dialysis

    Aurora, Illinois, 60504

  • DaVita JHHS Bond Street

    Baltimore, Maryland

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Clinical Research Center, Inc.

    Birmingham, Alabama, 35213

  • Table Rock Dialysis

    Boise, Idaho

  • Pharmaceutical Research Organization

    Bountiful, Utah

  • PAB Clinical Resesarch

    Brandon, Florida, 33511

  • Brenham

    Brenham, Texas

  • Kidney Care Associates, PLLC

    Brooklyn, New York, 11212

  • Angelo Magno, MD

    Brooklyn, New York, 11228

  • Brookdale Physicians Dialysis associates, P.C.

    Brooklyn, New York

  • University of Vermont, Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Nephrology Assciates of Central PA, INC

    Camp Hill, Pennsylvania, 17011

  • Celia Dill Dialysis Center

    Carmel, New York

  • University of North Carolina Division of Nephrology & Hypertension

    Chapel Hill, North Carolina, 27599

  • Charlotte Dialysis

    Charlotte, North Carolina

  • Jefferson Nephrology Ltd

    Charlottesville, Virginia, 22902

  • Great Bridge Dialysis Center

    Chesapeake, Virginia

  • University of Chicago Medical Center

    Chicago, Illinois, 60617

  • University of Cincinnati

    Cincinnati, Ohio, 45206

  • Nephrology and Hypertension

    Clinton, Maryland, 20735

  • Health Sciences Center

    Columbia, Missouri, 65212

  • South Florida Nephrology Group

    Coral Springs, Florida

  • California Kidney Specialist

    Covina, California, 91723

  • Atlantic Avenue Medical Clinic

    Cudahy, California, 90201

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Nephrology Consultants, PA

    Daytona Beach, Florida, 32114

  • Purity Dialysis Centers

    Delafield, Wisconsin, 53018

  • Associates in Nephrology

    Des Plaines, Illinois, 60016

  • Douglas Dialysis

    Douglas, Georgia

  • Renal Physicians of Georgia

    Dublin, Georgia, 31021

  • Hypertension & Nephrology Associates, PA

    Eatontown, New Jersey, 07724

  • DaVita Edison

    Edison, New Jersey

  • Kidney Consultants fo El Paso, P.A.

    El Paso, Texas

  • Albemarle Nephrology Associates

    Elizabeth City, North Carolina, 27909

  • AMS Research

    Elmira, New York, 14905

  • Renal Care of Erie

    Erie, Pennsylvania, 16502

  • Evanston Northwestern Healthcare

    Evanston, Illinois, 60201

  • Nephrology Associates, LLC

    Evansville, Indiana, 47714

  • Associates in Nephrology

    Evergreen Park, Illinois, 60805

  • Exton Dialysis Center

    Exton, Pennsylvania, 19341

  • Nephrology Associates of Northern Virgina

    Fairfax, Virginia, 22033

  • Horowitz and Krahn

    Fall River, Massachusetts, 02720

  • Nephrology Associates, PC

    Flushing, New York, 11355

  • TriMark Physicians Group

    Fort Dodge, Iowa, 50501

  • DaVita Fort Myers

    Fort Myers, Florida

  • DaVita Frederick Dialysis #3373

    Frederick, Maryland

  • Nephrology Associates

    Ft. Pierce, Florida, 34950

  • Nephrology Specialists PC

    Gary, Indiana, 46408

  • Glen Burnie Dialysis Center

    Glen Burnie, Maryland

  • Altru Health System Research Center

    Grand Forks, North Dakota, 58201

  • PDI Grand Rapids East

    Grand Rapids, Michigan

  • North Shore University Hospital

    Great Neck, New York, 11021

  • Promod K. Duggal, MD, PC

    Greenbelt, Maryland, 20770

  • Carolina Nephrology, PA

    Greenville, South Carolina, 29605

  • North Suburban Nephrology, LLC

    Gurnee, Illinois, 60031

  • Dialysis Care of Richmond County

    Hamlet, North Carolina

  • Hartford North

    Hartford, Connecticut

  • East Bay-South Hayward Dialysis Center

    Hayward, California, 94544

  • Clinical Research Consultants

    Hoover, Alabama

  • Med-Center Dialysis

    Houston, Texas, 77002

  • Innovative Renal Care

    Houston, Texas, 77003

  • Med-Center Dialysis

    Houston, Texas, 77004

  • Northwest Kidney Center

    Houston, Texas, 77004

  • Greater Houston Kidney Specialist

    Houston, Texas, 77030

  • Kidney Associates, PLLC

    Houston, Texas, 77030

  • Northwest Kidney Center

    Houston, Texas, 77092

  • DaVita Northstar Dialysis

    Houston, Texas

  • Outcomes Research International, Inc

    Hudson, Florida, 34668

  • Internal Medicine Nephrology/Hypertension

    Kingstree, South Carolina, 29556

  • Newman

    Knoxville, Tennessee, 37921

  • G. Edward Newman, MD, PLLC

    Knoxville, Tennessee, 37923

  • Gundersen Lutheran, Ltd

    La Crosse, Wisconsin, 54601

  • Central Florida Kidney Care, PA

    Lakeland, Florida, 33805

  • Lakewood Community Dialysis Center

    Lakewood, Washington

  • Davita Lancaster

    Lancaster, Pennsylvania

  • Mid Michigan Kidney Specialists

    Lansing, Michigan, 48912

  • Lawrenceburg Dialysis Center

    Lawrenceburg, Indiana, 47025

  • Lewistown Dialysis Center

    Lewistown, Pennsylvania, 17044

  • Lake County

    Libertyville, Illinois

  • Renal Research Center

    Los Alamitos, California, 90720

  • USC Kidney Center

    Los Angeles, California, 90033

  • Beverly Nephrology

    Los Angeles, California, 90048

  • Tower Nephrology Medical Group

    Los Angeles, California, 90048

  • USC DaVita Dialysis Center

    Los Angeles, California

  • Renal Medical Associates

    Lynwood, California, 90262

  • Renal Physicians of Georgia

    Macon, Georgia, 31217

  • West Bank Nephrology

    Marrero, Louisiana, 70072

  • Piedmont Medical and Renal Associates

    Martinsville, Virginia, 24112

  • Internal Medicina and Nephrology

    Maynardville, Tennessee, 37807

  • Memphis Central DaVita

    Memphis, Tennessee

  • Miami Kidney Group

    Miami, Florida, 33143

  • Nephrology Associates of South Miami

    Miami, Florida, 33173

  • Nephrology Specialists

    Michigan City, Indiana, 46360

  • University of South Alabama

    Mobile, Alabama, 36617

  • Reading Nephrology, Ltd.

    Mohnton, Pennsylvania, 19540

  • Montgomery Kidney Specialists

    Montgomery, Alabama, 36106

  • Center for Kidney Care

    Mount Laurel, New Jersey

  • Renal Associates of Central Indiana

    Muncie, Indiana, 47303

  • Renal Associates of Central Indiana

    Muncie, Indiana, 47304

  • Ball Memorial Hospital

    Muncie, Indiana

  • Nampa DaVita Dialysis

    Nampa, Idaho

  • VA Tennessee Valley, Health Care System

    Nashville, Tennessee, 37212

  • Metabolism Associates

    New Haven, Connecticut, 06511

  • LSU Healthcare Network

    New Orleans, Louisiana, 70112

  • Westbank Chronic Renal Center

    New Orleans, Louisiana

  • Lower Manhattan Dialysis Center

    New York, New York, 10016

  • Bronx Dialysis center

    New York, New York

  • Peninsula Dialysis

    Newport News, Virginia, 23604

  • Charleston Nephrology Associates

    North Charleston, South Carolina

  • Valley Renal Medical Group

    Northridge, California, 91324

  • Nephrology of Northern Utah

    Ogden, Utah

  • Olathe DaVita

    Olathe, Kansas

  • Nephrology Associates of Central Florida

    Orlando, Florida, 32804

  • Fox Valley Nephrology Partners, PC

    Oshkosh, Wisconsin, 54904

  • DaVita-Johnson County Dialysis

    Overland Park, Kansas

  • Rivertowne Davita Dialysis

    Oxon Hill, Maryland, 20745

  • Desert Nephrolgy Medical Group

    Palm Springs, California, 92262

  • Palo Alto Nephrology

    Palo Alto, California, 94304

  • Nephrology Associates Research Center

    Panama City, Florida, 32401

  • Nephrology & Hypertension Consultants, PC

    Park Ridge, Illinois, 60068

  • Pasadena Nephrology

    Pasadena, California, 91105

  • A Unique Kidney Center, LLC

    Pembroke Pines, Florida, 33024

  • Renal Care Associates

    Peoria, Illinois

  • Pennyslvania Nephrology Associates, PC

    Philadelphia, Pennsylvania, 19106

  • Davita West Philadelphia

    Philadelphia, Pennsylvania

  • Franklin Dialysis Center

    Philadelphia, Pennsylvania

  • PharmResearch, Inc.

    Pinecrest, Florida, 33156

  • Davita-Greater Portsmouth

    Portsmouth, Virginia

  • Portsmouth Dialysis Center-DaVita

    Portsmouth, Virginia

  • Syed Shah

    Pottsville, Pennsylvania, 17901

  • Central Utah Clinic

    Provo, Utah, 84604

  • Dialysis Care of Hoke County

    Raeford, North Carolina

  • Reidsville Dialysis

    Reidsville, North Carolina

  • Nephrology Specialists, PC

    Richmond, Virginia, 23229

  • Nephrology Associates

    Rochester, New York, 14626

  • University of Rochester Nephrology Unit

    Rochester, New York, 14642

  • Biolab Research, LLC

    Rockville, Maryland, 20852

  • Island Renal Associates, PC

    Rockville Centre, New York, 11570

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Capital Nephrology

    Sacramento, California, 95825

  • Syed Shah

    Saint Clair, Pennsylvania, 17970

  • Citrus Valley Dialysis Center

    San Bernardino, California

  • California Kidney Specialist

    San Dimas, California, 91773

  • San Francisco Dialysis Center # 3830

    San Francisco, California

  • Habib A. Tobbagi, MD

    San Jose, California, 95112

  • Sauget Dialysis

    Sauget, Illinois, 62206

  • Williams Street Dialysis

    Savannah, Georgia

  • Selma DaVita Dialysis

    Selma, California

  • Northwest Louisiana Nephrology, LLC

    Shreveport, Louisiana, 71101

  • Southern Pines Dialysis

    Southern Pines, South Carolina

  • Western New England Renal Transplant Association

    Springfield, Massachusetts, 01107

  • Clinical Research Development Association, LLC

    Springfield Gardens, New York, 11413

  • Douglas T. Domoto MD, JD, PC

    St Louis, Missouri, 63103

  • Washington University School of Medicine

    St Louis, Missouri, 63108

  • Saint Louis University Department of Internal Medicine

    St Louis, Missouri, 63110

  • SUNY at Stony Brook NY

    Stony Brook, New York, 11794

  • Syosset Kidney Center

    Syosset, New York, 11791

  • Tampa Bay Nephrology Associates

    Tampa, Florida, 33603

  • Genesis Clinical Research

    Tampa, Florida, 33614

  • Nephrology Consultants of Northwest Ohio

    Toledo, Ohio, 43606

  • Veritas Clinical Specialists, Ltd

    Topeka, Kansas, 66606

  • Dennis Artzer

    Topeka, Kansas

  • Torrington Dialysis

    Torrington, Connecticut

  • Pear Tree Dialysis

    Ukiah, California

  • Davita of Landover

    Upper Marlboro, Maryland

  • High Desert Nephrology

    Victorville, California, 92395

  • Cumberland Nephrology Associates, PA

    Vineland, New Jersey, 08360

  • Renal Medical Group

    Visalia, California, 93277

  • Macomb Kidney Center

    Warren, Michigan

  • Washington Dialysis

    Washington, Pennsylvania, 15301

  • Davita-Brentwood

    Washington D.C., District of Columbia

  • Lee Street Dialysis

    Washington D.C., District of Columbia

  • Union Plaza Dialysis Center

    Washington D.C., District of Columbia

  • Waycross Dialysis Facility

    Waycross, Georgia, 31501

  • Waycross Dialysis Facility

    Waycross, Georgia

  • Dialyis Corporation of America

    Wellsboro, Pennsylvania, 16901

  • Reading Nephrology, Ltd.

    West Reading, Pennsylvania, 19611

  • Carroll County Dialysis Facility

    Westminster, Maryland, 21157

  • Patel

    Wichita Falls, Texas, 76301

  • Southeastern Nephrology Associates

    Wilmington, North Carolina, 28401

  • DaVita Wilson Dialysis #3032

    Wilson, North Carolina

  • Nephrology Associates, PLLC

    Winston-Salem, North Carolina, 27103

  • Reading Nephrology, Ltd

    Wyomissing, Pennsylvania, 19610

  • Yonkers Nephrology, PC

    Yonkers, New York, 10710

  • Saint Elizabeth Healthcare Department of Research

    Youngstown, Ohio, 44501

  • NAI fo Kidney Care

    Youngstown, Ohio, 44514

  • North Valley Nephrology

    Yuba City, California, 95991

Other trials in United States

About this study

Official title: A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)

Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.

Medical subject headings
Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00567723
Study groupRoleWhat they receive
1Test group: Patients who have received a minimum of 12 consecutive weeks of treatment with Fosrenol
2Historical control group: Patients with no lanthanum exposure
3Concomitant therapy group: Patients being treated for hyperphosphatemia with any marketed product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD)

    Measured: 5 years

Secondary outcomes (1)

  1. Compare the incidence of selected morbidities among three groups of patients with ESRD

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2007 (estimated)
  2. Study start25 Apr 2006
  3. Primary completion7 Jun 2016
  4. Study completion7 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00567723
Sponsor's protocol ID
SPD405-404
Status last verified
Mar 2021
First submitted
3 Dec 2007
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
No

Publications

  • Hutchison A, Whelton A, Thadhani R, Achenbach H, Vergani A, Wu J, Hall G. Long-Term Mortality and Bone Safety in Patients with End-Stage Renal Disease Receiving Lanthanum Carbonate. Nephron. 2018;140(4):265-274. doi: 10.1159/000492603. Epub 2018 Oct 23.

    PubMed 30352437

  • Hutchison AJ, Wilson RJ, Garafola S, Copley JB. Lanthanum carbonate: safety data after 10 years. Nephrology (Carlton). 2016 Dec;21(12):987-994. doi: 10.1111/nep.12864.

    PubMed 27479781

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperphosphatemia, run by Shire at 199 sites in United States.

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 5 inclusion and 1 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: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD) (time frame: 5 years). 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 NCT00567723, which also lists 2 linked publications.

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 17 Mar 2021.

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