AnemiaPhase 3NCT02174627
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis
A Phase 3 study testing Roxadustat in people with Anemia, run by AstraZeneca at 359 sites in 26 countries.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Anemia
- What is being tested?
- Roxadustat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,781 participants
- Where
- 359 sitesin 26 countries
- Study dates
- 26 Jun 2014to 4 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Age ≥18 years at screening visit 1
- eGFR <60 mL/min/1.73 m2, (calculated by central lab) corresponding to stage 3, 4 or 5CKD according to the Kidney Disease Outcomes Quality Initiative (KDOQI), not receiving dialysis
- Mean of 2 most recent central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <10.0 g/dL
- Ferritin ≥50 ng/mL at randomization (obtained from screening visit)
- TSAT ≥15 % at randomization (obtained from screening visit)
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- Serum folate level ≥ lower limit of normal (LLN) at randomization (obtained from screening visit)
- Serum vitamin B12 level ≥LLN at randomization (obtained from screening visit)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin (Tbili) ≤1.5 x ULN at randomization (obtained from screening visit)
- Body weight 45 to 160 kg
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous randomization in the present study
- Any erythropoietin analogue treatment within 6 weeks of randomization
- New York Heart Association Class III or IV congestive heart failure at enrollment
- Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization
- History of chronic liver disease (e.g., chronic infectious hepatitis, chronic auto- immune liver disease, cirrhosis or fibrosis of the liver)
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- Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD
- Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis)
- Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening or within 12 weeks prior to randomization
- Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization. Patients may be rescreened once BP controlled
- History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
- Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
- Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia
- Known hemosiderosis, hemochromatosis or hypercoagulable condition
- Any prior organ transplant or a scheduled organ transplantation date
- Any red blood cell transfusion (RBC) during the screening period
- Any current condition leading to active significant blood loss
- Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of IP in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded)
- History of alcohol or drug abuse within 2 years prior to randomization
- Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence
- Pregnant or breastfeeding females
- Known allergy to the investigational product or any of its ingredients
- Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound efficacy or safety assessment or may interfere with study participation
Trial locations and contacts
359 sites in 26 countries.
359 sites in 26 countries
United States97 sites
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Arvada, Colorado, 80002
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Atlanta, Georgia, 30342
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Aventura, Florida, 33180
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Bakersfield, California, 93309
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Bethlehem, Pennsylvania, 18017
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Birmingham, Alabama, 35209
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Charlotte, North Carolina, 28207
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Cincinnati, Ohio, 45206
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Cincinnati, Ohio, 45220
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Columbia, South Carolina, 29203
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Columbus, Georgia, 31901
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Columbus, Georgia, 31904
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Columbus, Ohio, 43215
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Coral Gables, Florida, 33134
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Coral Springs, Florida, 33071
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Corpus Christi, Texas, 78404
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Cypress, Texas, 77429
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Dallas, Texas, 75231
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Edgewater, Florida, 32132
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El Centro, California, 92243
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Escondido, California, 92025
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Flushing, New York, 11355
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Glendale, California, 91204
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Great Neck, New York, 11021
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Greenbelt, Maryland, 20770
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Gulfport, Mississippi, 39501
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High Point, North Carolina, 27262
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Hollywood, Florida, 33021
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Houston, Texas, 77004
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Houston, Texas, 77024
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Houston, Texas, 77074
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Houston, Texas, 77084
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Houston, Texas, 77090
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Houston, Texas, 77099
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Huntsville, Alabama, 35805
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Jacksonville, North Carolina, 28546
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Joliet, Illinois, 60435
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Kansas City, Missouri, 64111
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Kissimmee, Florida, 34741
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Knoxville, Tennessee, 37923
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La Grange, Illinois, 60525
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Lansdale, Pennsylvania, 19446
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Las Vegas, Nevada, 89106
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Las Vegas, Nevada, 89128
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Lauderdale Lakes, Florida, 33313
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Long Beach, California, 90806
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Long Beach, California, 90807
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Los Angeles, California, 90022
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Los Angeles, California, 90095
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Lufkin, Texas, 75904
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Lynwood, California, 90262
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Metairie, Louisiana, 70006
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Miami, Florida, 33126
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Miami, Florida, 33130
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Miami, Florida, 33133
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Miami, Florida, 33145
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Miami, Florida, 33150
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Miami, Florida, 33165
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Miami, Florida, 33169
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Miami, Florida, 33173
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National City, California, 91950
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New Bern, North Carolina, 28562
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Norfolk, Virginia, 23507
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Northridge, California, 91324
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Oklahoma City, Oklahoma, 73116
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Omaha, Nebraska, 68124
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Orange, California, 92868
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Philadelphia, Pennsylvania, 19104
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Phoenix, Arizona, 85027
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Port Charlotte, Florida, 33952
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Port Huron, Michigan, 48060
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Providence, Rhode Island, 02908
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Providence, Rhode Island, 02915
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Reno, Nevada, 89511
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Rochester, New Hampshire, 03867
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Rockport, Maine, 04856
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Rockville, Maryland, 20852
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Sacramento, California, 95825
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Sacramento, California, 95831
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Salem, Virginia, 24153
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Salt Lake City, Utah, 84115
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San Antonio, Texas, 78207
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San Antonio, Texas, 78212
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San Antonio, Texas, 78229
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San Antonio, Texas, 78258
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San Diego, California, 92103
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San Dimas, California, 91773
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San Francisco, California, 94110
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San Luis Obispo, California, 93401
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Shreveport, Louisiana, 71101
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St. George, Utah, 84790
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Tampa, Florida, 33607
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Uniontown, Pennsylvania, 15401
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Upland, California, 91786
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Waterbury, Connecticut, 06708
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Wilmington, North Carolina, 28401
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Woodbridge, Virginia, 22191
Ukraine24 sites
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Chernivtsi, 58002
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Dnipro, 49005
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Ivano-Frankivsk, 76008
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Kharkiv, 61002
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Kharkiv, 61039
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Kharkiv, 61058
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Kharkiv, 61103
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Khmelnytsky, 29000
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Kirovograd, 25006
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Kyiv, 01601
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Kyiv, 02125
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Kyiv, 04050
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Kyiv, 04107
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Kyiv, 04114
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Lutsk, 43005
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Lviv, 79010
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Odesa, 65009
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Rivne, 33027
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Vinnytsia, 21018
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Vinnytsia, 21029
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Zaporizhzhya, 69001
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Zaporizhzhya, 69068
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Zaporizhzhya, 69118
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Zaporizhzhya, 69600
Canada22 sites
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Brampton, Ontario, L6R 3J7
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Brampton, Ontario, L6T 0G1
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Edmonton, Alberta, T6G 2B7
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Gatineau, Quebec, J8Y 6S8
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Greenfield Park, Quebec, J4V 2H1
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Kamloops, British Columbia, V2C 2T1
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Kitchener, Ontario, N2H 5Z8
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London, Ontario, N6A 5A5
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H4J 1C5
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New Westminster, British Columbia, V3L 0A6
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Oakville, Ontario, L6K 3V3
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Québec, Quebec, G1R 2J6
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Saint John, New Brunswick, E2L 4L2
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Scarborough Village, Ontario, M1H 3G4
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Sydney, Nova Scotia, B1P 1P3
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Toronto, Ontario, M4C 5T2
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Toronto, Ontario, M4S 1Y2
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Toronto, Ontario, M5C 2T2
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Toronto, Ontario, M9N 1N8
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Whitby, Ontario, L1N 5T2
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Winnipeg, Manitoba, R2V 3M3
India22 sites
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Ahmedabad, 380016
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Bangalore, 560052
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Bangalore, 560068
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Bangalore, 560070
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Chennai, 600006
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Ghaziabad NCR, 201012
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Hyderabad, 500018
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Hyderabad, 500072
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Kolkata, 700027
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Lucknow, 226003
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Maharashtra, 411013
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Mumbai, 400008
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Mysore, 570004
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Nagpur, 420012
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Nagpur, 440003
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Nagpur, 440012
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New Delhi, 110017
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New Delhi, 110060
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Pune, 411001
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Vijayawada, 520 008
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Vijayawada, 522002
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Visakhapatnam, 530002
Russia20 sites
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Arkhangelsk, 163001
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Barnaul, 656024
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Irkutsk, 664049
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Izhevsk, 426035
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Kemerovo, 650066
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Krasnoyarsk, 660062
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Moscow, 105229
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Moscow, 109263
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Moscow, 129344
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Nizhny Novgorod, 603076
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Nizhny Novgorod, 603126
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Perm, 614000
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Ryazan, 390027
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Saint Petersburg, 191015
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Saint Petersburg, 194354
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Saint Petersburg, 196601
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Ufa, 450000
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Ufa, 450005
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Ufa, 450071
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Volgograd, 404120
Brazil19 sites
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Curitiba, 80230-130
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Curitiba, 80440-020
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Curitiba, 80810-040
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Feira de Santana, 44001-584
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Fortaleza, 60115282
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Fortaleza, 60430-350
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Fortaleza, 60430-370
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Goiânia, 74043-011
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Joinville
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Juiz de Fora, 36036-330
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Maringá, 87083-240
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Porto Alegre, 90035-003
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Porto Alegre, 90160-093
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Porto Alegre, 90610-000
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São Bernardo do Campo, 09715090
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São Paulo, 01323-030
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São Paulo, 04039-000
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São Paulo, 05403-000
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São Paulo, 08270-070
Argentina16 sites
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CABA, C1012AAR
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CABA, C1440AAD
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Capital Federal, C1425AGC
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Ciudad Autónoma de Bs. As., C1199ABB
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Ciudadela, 1702
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La Plata, 1900
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La Plata, C1427ARO
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Lanus, B1824KAJ
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Mar del Plata, 7600
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Munro, 1605
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Ramos Mejía, B1704ETD
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Rosario, 2000
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Rosario, S2000DNM
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San Isidro, B1642DCD
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San Miguel de Tucumán, 4000
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Santa Rosa, 6300
Hungary13 sites
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Ajka, 8400
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Budapest, 1096
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Budapest, 1134
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Gyula, 5700
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Hatvan, 3000
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Kecskemét, 6000
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Nyíregyháza, 4400
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Pécs, 7623
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Polgár, 4090
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Salgótarján, 3100
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Siófok, 8600
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Tatabánya, 2800
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Velence, 2481
South Korea13 sites
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Ansan-si, 15355
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Busan, 49241
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Daegu, 42415
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Daejeon, 35015
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Goyang-si, 10380
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Goyang-si, 10444
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Incheon, 403-720
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Seongnam-si, 13620
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Seoul, 03312
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Seoul, 06273
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Seoul, 08308
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Seoul, 139-711
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Uijeongbu-si, 11765
Bulgaria11 sites
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Botevgrad, 2140
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Dupnitsa, 2600
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Gotse Delchev, 2900
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Haskovo, 6300
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Kozloduy, 3320
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Samokov, 2000
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Sandanski, 2800
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Silistra, 7500
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Sliven, 8800
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Smolyan, 3700
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Yambol, 8600
Czechia10 sites
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Brno, 625 00
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Havlíčkův Brod, 580 22
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Ivančice, 664 91
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Prague, 190 61
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Rychnov nad Kněžnou, 516 01
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Slaný, 274 01
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Slavkov u Brna
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Šumperk, 787 01
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Ústí nad Labem, 401 13
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Ústí nad Orlicí, 562 18
Taiwan10 sites
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Kaohsiung City, 82445
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Keelung, 20401
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New Taipei City, 220
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New Taipei City, 231
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New Taipei City, 23561
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Taichung, 402
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Taipei, 0116
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Taipei, 10491
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Taipei
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Taoyuan, 333
Peru9 sites
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Bellavista, CALLAO 2
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Ica
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Lima, 14
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Lima, L17
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Lima, LIMA 01
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Lima, LIMA 1
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Lima, LIMA 27
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Lima, LIMA 31
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Trujillo, 044
Mexico8 sites
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Aguascalientes, 20219
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Culiacán, 80230
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Guadalajara, 44670
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Guadalajara, 44676
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México, 06726
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Minatitlán, 96730
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Veracruz, 91900
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Xalapa, 91020
Puerto Rico8 sites
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Cidra, 00739
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Rio Grande, 00745
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Rio Piedras, 00935
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San Juan, 00909
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San Juan, 00917
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San Juan, 00921
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San Juan, 00927
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Toa Baja, 00949
Spain7 sites
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Almería, 04009
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Málaga, 29010
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Santiago de Compostela, 15706
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Seville, 41013
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Valencia, 46010
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Valencia, 46017
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Valencia, 46026
Turkey (Türkiye)7 sites
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Adana, 01330
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Ankara, 06230
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Ankara, 06490
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Antalya
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Istanbul, 34093
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Istanbul, 34098
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Izmir, 35040
Poland6 sites
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Ciechanów, 06-400
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Gmina Końskie, 26-200
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Lodz, 90-141
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Poznan, 60-355
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Sochaczew, 96-500
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Tczew, 83-110
Slovakia6 sites
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Bratislava, 82606
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Bratislava, 831 03
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Košice, 04011
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Kráľovský Chlmec, 077 01
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Nové Zámky, 940 34
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Zvolen, 960 01
Thailand6 sites
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Bangkok, 10300
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Bangkok, 10330
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Bangkok, 10400
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Bangkok, 10700
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Khon Kaen, 40000
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Khon Kaen, 40002
Vietnam6 sites
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Can Tho, 900000
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Hanoi, 100000
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Ho Chi Minh City, 700000
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Hochiminh, 550000
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Hochiminh, 700000
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Huế, 530000
Romania5 sites
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Arad, 310017
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Bucharest, 010731
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Bucharest, 020475
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Târgu Mureş, 540000
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Timișoara, 300736
Colombia4 sites
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Cali, 760032
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Chía, 250008
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Medellín, 5001000
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Zipaquirá, 250258
Malaysia4 sites
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George Town, 10990
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Kubang Kerian, 16150
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Putrajaya, 62250
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Taiping, 34000
Germany3 sites
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Berlin, 10117
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Cloppenburg, 49661
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Cologne, 50937
Philippines3 sites
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Cebu City, 6000
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Iloilo City, 5000
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Quezon City, 1101
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis
Read the detailed description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in anemic patients with Stage 3, 4 or 5 chronic kidney disease (CKD) who are not on dialysis.
- Conditions
- Anemia
- Being tested
- Roxadustat, Placebo
- Keywords
- Renal,, CKD,, Roxadustat,, anemia,, non-dialysis
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
PlaceboDrug
The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
| Study group | Role | What they receive |
|---|---|---|
| Roxadustat | Experimental | Not described Receives: Drug: Roxadustat |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation analysis of covariance (ANCOVA) model with baseline Hb, baseline estimated glomerular filtration rate (eGFR), cardiovascular (CV) history, geographic region and treatment group as fixed effect covariates. The adjusted least squares (LS) mean estimates of change from baseline to mean during Week 28 to Week 52 are presented.
Measured: Baseline (Day 1, Week 0) and Week 28 to Week 52.
Secondary outcomes (10)
Percentage of Participants With Hb Response During the First 24 Weeks of Treatment
Hb response was defined as:
- Hb ≥ 11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL for participants with baseline Hb > 8.0 g/dL; or
- Hb increase from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at 2 consecutive visits (with available data) separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (red blood cell [RBC] transfusion, erythropoietin analogue, or intravenous [IV] iron) prior to Hb response. The percentage of participants with an Hb response during the first 24 weeks of treatment is presented.
Measured: Baseline (Day 1, Week 0) up to Week 24.
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)
Baseline hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value during Week 28 to Week 52 was analyzed using a MAR based multiple imputation ANCOVA model with baseline Hb, baseline eGFR, CV history, geographic region and treatment group as fixed effect covariates. The adjusted LS mean estimates of change from baseline in participants with baseline hsCRP >ULN to mean during Week 28 to Week 52 are presented.
Measured: Baseline (Day 1, Week 0) and Week 28 to Week 52.
Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52
Proportion of total time of interpolated Hb values ≥10 g/dL was calculated as the time the linearly interpolated curve between measurements ≥10 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented.
Measured: Week 28 up to Week 52.
Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52
Proportion of total time of interpolated Hb values within the interval of 10 to 12 g/dL was calculated as the time the linearly interpolated curve between measurements were within 10 to 12 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented.
Measured: Week 28 up to Week 52.
Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24
Baseline LDL was defined as the last result obtained prior to randomization. Mean changes in LDL cholesterol from baseline to Week 24 was analyzed using an ANCOVA model with baseline LDL, baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented.
Measured: Baseline (Day 1, Week 0) and Week 24
Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy
Time-to-first rescue therapy (IV iron, RBC transfusion or erythropoietin analogue) was calculated as (date of first rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.
Measured: Baseline (Day1, Week 0) up to End of Study (EOS) visit (4 weeks after the treatment period) (or up to date of first rescue therapy), with treatment duration up to 4 years.
Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy
Time-to-first RBC rescue therapy was calculated as (date of first RBC rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.
Measured: Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period) (or up to date of first RBC rescue therapy), with treatment duration up to 4 years.
Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28
SF-36 is a Quality of Life (QoL) scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Vitality sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a mixed model for repeated measures (MMRM) with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented.
Measured: Baseline (Day 1, Week 0) and Week 12 to Week 28.
Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant
Baseline eGFR was defined as the mean of all available central laboratory values prior to or at randomization. Rate of change in eGFR from baseline during the entire treatment period (in millilitres/minute/1.73 meters squared/years [mL/min/1.73m^2/years]) was estimated using a random effects model using all post-baseline eGFR values prior to initiation of dialysis/transplant. Baseline eGFR, baseline Hb, geographic region, CV history, treatment group and post-baseline eGFR measurement time were used as fixed effects and participant and time (years) as random effects, ie, random intercept and slope.
Measured: Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period), with treatment duration up to 4 years.
Mean Change From Baseline in SF-36 Physical Functioning Sub-Score From Week 12 to Week 28
SF-36 is a QoL scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Physical Functioning sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a MMRM with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented.
Measured: Baseline (Day 1, Week 0) and Week 12 to Week 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study start26 Jun 2014
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,781 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Responsible party
- Sponsor
- Investigators
- Steven Fishbane, MD, Principal investigator, Chief Division of Kidney Diseases and Hypertension, North Shore University Hospital, Great Neck, NY, USAMark Houser, MD, Study director, AZ R&D Gaithersburg, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174627
- Sponsor's protocol ID
- D5740C00001
- Status last verified
- Nov 2019
- First submitted
- 24 Jun 2014
- Last updated
- 16 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278Provenzano R, Szczech L, Leong R, Saikali KG, Zhong M, Lee TT, Little DJ, Houser MT, Frison L, Houghton J, Neff TB. Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent CKD: Pooled Results of Three Randomized Clinical Trials. Clin J Am Soc Nephrol. 2021 Aug;16(8):1190-1200. doi: 10.2215/CJN.16191020.
PubMed 34362786Fishbane S, El-Shahawy MA, Pecoits-Filho R, Van BP, Houser MT, Frison L, Little DJ, Guzman NJ, Pergola PE. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. J Am Soc Nephrol. 2021 Mar;32(3):737-755. doi: 10.1681/ASN.2020081150. Epub 2021 Feb 10.
PubMed 33568383
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
- ClinicalTrials.gov ID
- NCT02174627
- Acronym / sponsor ID
- D5740C00001
- Conditions
- Anemia
- Keywords
- Renal,, CKD,, Roxadustat,, anemia,, non-dialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,781 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Kyntra Bio
- Study start
- 26 Jun 2014 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Posted 16 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis
Detailed description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in anemic patients with Stage 3, 4 or 5 chronic kidney disease (CKD) who are not on dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxadustat | Experimental | Drug: Roxadustat |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of informed consent prior to any study specific procedures.
- Age ≥18 years at screening visit 1
- eGFR <60 mL/min/1.73 m2, (calculated by central lab) corresponding to stage 3, 4 or 5CKD according to the Kidney Disease Outcomes Quality Initiative (KDOQI), not receiving dialysis
- Mean of 2 most recent central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <10.0 g/dL
- Ferritin ≥50 ng/mL at randomization (obtained from screening visit)
Key exclusion criteria (24 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous randomization in the present study
- Any erythropoietin analogue treatment within 6 weeks of randomization
- New York Heart Association Class III or IV congestive heart failure at enrollment
- Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization
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 |
|---|---|---|
| RoxadustatThe initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL. | Drug | Roxadustat |
| PlaceboThe initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL. | Drug | Placebo |
Primary outcome
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52
Time frame: Baseline (Day 1, Week 0) and Week 28 to Week 52.
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation analysis of covariance (ANCOVA) model with baseline Hb, baseline estimated glomerular filtration rate (eGFR), cardiovascular (CV) history, geographic region and treatment group as fixed effect covariates. The adjusted least squares (LS) mean estimates of change from baseline to mean during Week 28 to Week 52 are presented.
10 secondary outcomes
Percentage of Participants With Hb Response During the First 24 Weeks of Treatment
Time frame: Baseline (Day 1, Week 0) up to Week 24.
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)
Time frame: Baseline (Day 1, Week 0) and Week 28 to Week 52.
Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52
Time frame: Week 28 up to Week 52.
Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52
Time frame: Week 28 up to Week 52.
Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24
Time frame: Baseline (Day 1, Week 0) and Week 24
Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy
Time frame: Baseline (Day1, Week 0) up to End of Study (EOS) visit (4 weeks after the treatment period) (or up to date of first rescue therapy), with treatment duration up to 4 years.
Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy
Time frame: Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period) (or up to date of first RBC rescue therapy), with treatment duration up to 4 years.
Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28
Time frame: Baseline (Day 1, Week 0) and Week 12 to Week 28.
Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant
Time frame: Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period), with treatment duration up to 4 years.
Mean Change From Baseline in SF-36 Physical Functioning Sub-Score From Week 12 to Week 28
Time frame: Baseline (Day 1, Week 0) and Week 12 to Week 28.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- Derived from this study: PubMed 34362786Provenzano R, Szczech L, Leong R, Saikali KG, Zhong M, Lee TT, Little DJ, Houser MT, Frison L, Houghton J, Neff TB. Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent CKD: Pooled Results of Three Randomized Clinical Trials. Clin J Am Soc Nephrol. 2021 Aug;16(8):1190-1200. doi: 10.2215/CJN.16191020.
- Derived from this study: PubMed 33568383Fishbane S, El-Shahawy MA, Pecoits-Filho R, Van BP, Houser MT, Frison L, Little DJ, Guzman NJ, Pergola PE. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. J Am Soc Nephrol. 2021 Mar;32(3):737-755. doi: 10.1681/ASN.2020081150. Epub 2021 Feb 10.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Steven Fishbane, MD principal investigator
Chief Division of Kidney Diseases and Hypertension, North Shore University Hospital, Great Neck, NY, USA
Mark Houser, MD study director
AZ R&D Gaithersburg, USA
359 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roxadustat in people with Anemia, run by AstraZeneca at 359 sites in 26 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 10 inclusion and 24 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 359 sites in United States, Ukraine, Canada, India, Russia and 21 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 (time frame: Baseline (Day 1, Week 0) and Week 28 to Week 52.). 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 NCT02174627, which also lists 3 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 16 Dec 2019.