Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.
A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients
1 other identifier
interventional
2,133
18 countries
188
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2014
Typical duration for phase_3
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2018
CompletedResults Posted
Study results publicly available
December 16, 2019
CompletedDecember 16, 2019
November 1, 2019
4.2 years
June 24, 2014
September 26, 2019
November 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52
Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation Analysis of Covariance (ANCOVA). Baseline Hb was used as a covariate and treatment group, cardiovascular (CV) history, geographic region and dialysis duration as fixed effects. The adjusted least squares (LS) mean estimates of change from baseline during Week 28 to Week 52 are presented.
Baseline (Day 1, Week 0), Week 28 to 52
Secondary Outcomes (7)
Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period
Baseline (Day 1, Week 0), Week 28 to 36
Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52
Week 28 to 52
Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52
Week 28 to 52
Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24
Baseline (Day 1, Week 0) to Week 24
Mean Change in Hb From Baseline to the Participant's Mean Level Between Week 28 to Week 52 in Participants With Baseline High-Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)
Baseline (Day 1, Week 0), Week 28 to 52
- +2 more secondary outcomes
Study Arms (2)
Roxadustat
EXPERIMENTALEpoetin alfa
ACTIVE COMPARATORInterventions
Roxadustat will be administered orally three times a week (TIW) to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.
Epoetin alfa will be administered TIW consistent with approved prescribing information for epoetin alfa to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.
Eligibility Criteria
You may qualify if:
- Provision of Informed Consent prior to any study specific procedures
- Age ≥18 years at screening visit 1
- Previous versions of the protocol prior to US amendment ver 6.0 and outside of US amendment ver 7.0:
- Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease (ESRD) at least 30 days prior to visit 1. Patients treated with hemodialysis must have access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter. Patients on peritoneal dialysis must have a functioning peritoneal dialysis catheter in place.
- Starting with US amendment ver. 6.0 and outside of US amendment ver 7.0 (changed to recruit incident dialysis patients only):
- Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease (ESRD) for a minimum of 2 weeks and a maximum of 4 months prior to randomization. Patients treated with hemodialysis must have access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter. Patients on peritoneal dialysis must have a functioning peritoneal dialysis catheter in place.
- Two central laboratory Hb values during the screening period, obtained at least 7 days apart, must be \<12 g/dL in patients currently treated with an erythropoietin analogue or \<10 g/dL in patients not currently treated with an erythropoietin analogue. Patients are considered not currently treated if they have not received either Mircera® for at least 8 weeks or any other erythropoietin analogue for at least 4 weeks prior to visit 1.
- Ferritin ≥100 ng/mL at randomization (obtained from screening visit)
- TSAT ≥20% at randomization (obtained from screening visit)
- 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) ≤3x 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 (prescribed dry weight)
You may not qualify if:
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous randomisation in the present study
- New York Heart Association Class III or IV congestive heart failure at enrolment
- Myocardial infarction, 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)
- 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.
- Uncontrolled hypertension at the time of randomization (defined as systolic BP ≥180 mmHg or diastolic BP ≥100 mmHg on repeated measurement post-dialysis in hemodialysis patients or at any time in peritoneal dialysis patients), contraindication to epoetin alfa treatment (e.g., pure red cell aplasia, hypersensitivity or know inability to tolerate epoetin alfa)
- 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, 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 with the exception of an autologous renal transplant or a renal transplant that was subsequently removed ("explanted") or scheduled organ transplantation date
- Any red blood cell (RBC) transfusion during the screening period
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Kyntra Biocollaborator
Study Sites (188)
Research Site
Huntsville, Alabama, 35805, United States
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El Centro, California, 92243, United States
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Fairfield, California, 94534, United States
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Glendale, California, 91205, United States
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Long Beach, California, 90802, United States
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Long Beach, California, 90807, United States
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Los Angeles, California, 90022, United States
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Los Angeles, California, 90025, United States
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Lynwood, California, 90262, United States
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Northridge, California, 91324, United States
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Ontario, California, 91762, United States
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Orange, California, 92868, United States
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Riverside, California, 92503, United States
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Sacramento, California, 95825, United States
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Sun Valley, California, 91352, United States
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Whittier, California, 90602, United States
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Whittier, California, 90606, United States
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Denver, Colorado, 80230, United States
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New Haven, Connecticut, 06510, United States
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Miami Gardens, Florida, 33169, United States
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River Forest, Illinois, 60305, United States
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Wichita, Kansas, 67214, United States
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Baton Rouge, Louisiana, 70808, United States
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Lanham, Maryland, 20706, United States
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Plymouth, Massachusetts, 02360, United States
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Roseville, Michigan, 48066, United States
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Gulfport, Mississippi, 39501, United States
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Kansas City, Missouri, 64111, United States
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Reno, Nevada, 89511, United States
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Paterson, New Jersey, 07504, United States
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Great Neck, New York, 11021, United States
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Orchard Park, New York, 14127, United States
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The Bronx, New York, 10461, United States
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Asheville, North Carolina, 28805, United States
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Charlotte, North Carolina, 28207, United States
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Wilmington, North Carolina, 28401, United States
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Cincinnati, Ohio, 45206, United States
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Shawnee, Oklahoma, 74804, United States
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Bethlehem, Pennsylvania, 18017, United States
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Philadelphia, Pennsylvania, 19106, United States
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East Providence, Rhode Island, 02914, United States
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Austin, Texas, 78756, United States
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Austin, Texas, 78758, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77091, United States
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San Antonio, Texas, 78212, United States
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San Antonio, Texas, 78222, United States
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San Antonio, Texas, 78229, United States
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Newport News, Virginia, 23605, United States
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Sterling, Virginia, 20164, United States
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Bluefield, West Virginia, 24701, United States
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Camperdown, 2050, Australia
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Clayton, 3168, Australia
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Concord, 2139, Australia
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Launceston, 7250, Australia
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Prahan, 3004, Australia
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St Leonards, 2065, Australia
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Wahroonga, 2076, Australia
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Botevgrad, 2140, Bulgaria
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Dupnitsa, 2600, Bulgaria
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Gotse Delchev, 2900, Bulgaria
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Haskovo, 6300, Bulgaria
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Razlog, 2760, Bulgaria
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Samokov, 2000, Bulgaria
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Sandanski, 2800, Bulgaria
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Shumen, 9700, Bulgaria
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Silistra, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 3700, Bulgaria
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Yambol, 8600, Bulgaria
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Edmonton, Alberta, T6G 2B7, Canada
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Kamloops, British Columbia, V2C 2T1, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Scarborough Village, Ontario, M1P 2V5, Canada
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Toronto, Ontario, M3M 0B2, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H2X 3J4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1R 2J6, Canada
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Brno, 625 00, Czechia
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Prague, 140 00, Czechia
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Prague, 140 21, Czechia
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Prague, 190 61, Czechia
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Rychnov nad Kněžnou, 516 01, Czechia
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Slaný, 274 01, Czechia
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Tábor, 390 03, Czechia
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Ústí nad Labem, 401 13, Czechia
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Ajka, 8400, Hungary
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Budapest, 1076, Hungary
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Budapest, 1077, Hungary
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Budapest, 1097, Hungary
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Debrecen, 4043, Hungary
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Miskolc, 3526, Hungary
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Nagykanizsa, 8800, Hungary
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Székesfehérvár, 8000, Hungary
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Tatabánya, 2800, Hungary
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Chennai, 600006, India
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Ghaziabad NCR, 201012, India
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Hyderabad, 500018, India
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Kolkata, 700027, India
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Lucknow, 226003, India
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Maharashtra, 411013, India
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Mumbai, 400008, India
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Mysore, 570004, India
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Nadiād, 387001, India
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New Delhi, 110017, India
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New Delhi, 110060, India
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Pune, 411001, India
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Vellore, 632004, India
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Vijayawada, 520 008, India
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Aguascalientes, 20219, Mexico
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Guadalajara, 44670, Mexico
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México, 06700, Mexico
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Veracruz, 91900, Mexico
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Lima, 14, Peru
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Lima, L27, Peru
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Lima, LIMA 01, Peru
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Cebu City, 6000, Philippines
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Iloilo City, 5000, Philippines
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Ciechanów, 06-400, Poland
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Gmina Końskie, 26-200, Poland
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Katowice, 40-752, Poland
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Lodz, 90-153, Poland
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Lodz, 92-213, Poland
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Pszczyna, 43-200, Poland
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Suwałki, 16-400, Poland
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Tarnów, 33-100, Poland
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Warsaw, 02-758, Poland
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Arkhangelsk, 163001, Russia
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Barnaul, 656024, Russia
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Irkutsk, 664049, Russia
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Izhevsk, 426035, Russia
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Kemerovo, 650066, Russia
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Moscow, 105229, Russia
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Moscow, 123182, Russia
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Nizhny Novgorod, 603126, Russia
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Penza, 440034, Russia
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Perm, 614000, Russia
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Pyatigorsk, 357500, Russia
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Ryazan, 390027, Russia
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Saint Petersburg, 191015, Russia
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Ufa, 450071, Russia
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Banská Bystrica, 97517, Slovakia
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Banská Bystrica, Slovakia
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Bratislava, 82606, Slovakia
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Bratislava, 831 03, Slovakia
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Košice, 04011, Slovakia
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Kráľovský Chlmec, 077 01, Slovakia
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Nové Zámky, 940 34, Slovakia
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Zvolen, 960 01, Slovakia
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Almería, 04009, Spain
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Barcelona, 08029, Spain
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Granollers (Barcelona), 08400, Spain
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Málaga, 29010, Spain
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Seville, 41013, Spain
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Seville, 41071, Spain
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Tarragona, 43007, Spain
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Valencia, 46017, Spain
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Karlstad, 651 85, Sweden
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Stockholm, 141 86, Sweden
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Uppsala, 751 85, Sweden
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Västerås, 721 89, Sweden
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chernivtsi, 58002, Ukraine
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Dnipro, 49005, Ukraine
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Ivano-Frankivsk, 76008, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kyiv, 01601, Ukraine
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Kyiv, 02125, Ukraine
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Kyiv, 04050, Ukraine
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Kyiv, 04107, Ukraine
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Odesa, 65025, Ukraine
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Odesa, 65074, Ukraine
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Poltava, 36024, Ukraine
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Ternopil, 46002, Ukraine
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Uzhhorod, 88006, Ukraine
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Vinnytsia, 21018, Ukraine
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Zaporizhzhya, 69001, Ukraine
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Zaporizhzhya, 69118, Ukraine
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Zaporizhzhya, 69600, Ukraine
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Can Tho, 900000, Vietnam
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Hanoi, 100000, Vietnam
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Hochiminh, 700000, Vietnam
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Huế, 530000, Vietnam
Related Publications (4)
Hamano T, Yamaguchi Y, Goto K, Martin S, Jiletcovici A, Dellanna F, Akizawa T, Barratt J. Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials. Adv Ther. 2024 Apr;41(4):1553-1575. doi: 10.1007/s12325-023-02728-2. Epub 2024 Feb 16.
PMID: 38363466DERIVEDBarratt J, Dellanna F, Portoles J, Choukroun G, De Nicola L, Young J, Dimkovic N, Reusch M. Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies. Adv Ther. 2023 Apr;40(4):1546-1559. doi: 10.1007/s12325-023-02433-0. Epub 2023 Feb 7.
PMID: 36749544DERIVEDNatale 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.
PMID: 36005278DERIVEDFishbane S, Pollock CA, El-Shahawy M, Escudero ET, Rastogi A, Van BP, Frison L, Houser M, Pola M, Little DJ, Guzman N, Pergola PE. Roxadustat Versus Epoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis: Results from the Randomized Phase 3 ROCKIES Study. J Am Soc Nephrol. 2022 Apr;33(4):850-866. doi: 10.1681/ASN.2020111638.
PMID: 35361724DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
27 participants were excluded from the analysis due to Good Clinical Practice violations or system technical issues (17 in the roxadustat group and 10 in the epoetin alfa group).
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Fishbane, MD
Chief Division of Kidney Diseases and Hypertension, North Shore University Hospital, Great Neck, NY, USA
- STUDY DIRECTOR
Mark Houser, MD
AZ R&D, Gaithersburg, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 25, 2014
Study Start
July 1, 2014
Primary Completion
September 26, 2018
Study Completion
September 26, 2018
Last Updated
December 16, 2019
Results First Posted
December 16, 2019
Record last verified: 2019-11