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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: Roxadustat; Drug: Epoetin alfa

Detailed Description

This is a Phase 3, multicenter, randomized, open-label, active-controlled study to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in dialysis patients. Patients on hemodialysis (HD) or peritoneal dialysis (PD) who have been treated with an erythropoietin analogue or have an indication for treatment with an erythropoietin analogue will be evaluated for eligibility and randomized at a 1:1 ratio to treatment with roxadustat (with discontinuation of prior erythropoietin analogue therapy) or to an active-control group treated with epoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 2133
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Camperdown, Australia, 2050
    • Research Site
  • Clayton, Australia, 3168
    • Research Site
  • Concord, Australia, 2139
    • Research Site
  • Launceston, Australia, 7250
    • Research Site
  • Prahan, Australia, 3004
    • Research Site
  • St Leonards, Australia, 2065
    • Research Site
  • Wahroonga, Australia, 2076
    • Research Site
• Bulgaria
  • Botevgrad, Bulgaria, 2140
    • Research Site
  • Dupnitsa, Bulgaria, 2600
    • Research Site
  • Gotse Delchev, Bulgaria, 2900
    • Research Site
  • Haskovo, Bulgaria, 6300
    • Research Site
  • Razlog, Bulgaria, 2760
    • Research Site
  • Samokov, Bulgaria, 2000
    • Research Site
  • Sandanski, Bulgaria, 2800
    • Research Site
  • Shumen, Bulgaria, 9700
    • Research Site
  • Silistra, Bulgaria
    • Research Site
  • Sliven, Bulgaria, 8800
    • Research Site
  • Smolyan, Bulgaria, 3700
    • Research Site
  • Yambol, Bulgaria, 8600
    • Research Site
• Canada
  • Quebec, Canada, G1R 2J6
    • Research Site
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Research Site
  • British Columbia
    • Kamloops, British Columbia, Canada, V2C 2T1
      • Research Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Research Site
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Research Site
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • Research Site
    • Oshawa, Ontario, Canada, L1G 2B9
      • Research Site
    • Scarborough, Ontario, Canada, M1P 2V5
      • Research Site
    • Toronto, Ontario, Canada, M3M 0B2
      • Research Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Research Site
    • Montreal, Quebec, Canada, H4J 1C5
      • Research Site
    • Montreal, Quebec, Canada, H2X 3J4
      • Research Site
• Czechia
  • Brno, Czechia, 625 00
    • Research Site
  • Praha, Czechia, 190 61
    • Research Site
  • Praha 4, Czechia, 140 21
    • Research Site
  • Praha 4, Czechia, 140 00
    • Research Site
  • Rychnov nad Kneznou, Czechia, 516 01
    • Research Site
  • Slany, Czechia, 274 01
    • Research Site
  • Tabor, Czechia, 390 03
    • Research Site
  • Usti nad Labem, Czechia, 401 13
    • Research Site
• Hungary
  • Ajka, Hungary, 8400
    • Research Site
  • Budapest, Hungary, 1076
    • Research Site
  • Budapest, Hungary, 1097
    • Research Site
  • Budapest, Hungary, 1077
    • Research Site
  • Debrecen, Hungary, 4043
    • Research Site
  • Miskolc, Hungary, 3526
    • Research Site
  • Nagykanizsa, Hungary, 8800
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
  • Tatabánya, Hungary, 2800
    • Research Site
• India
  • Chennai, India, 600006
    • Research Site
  • Ghaziabad NCR, India, 201012
    • Research Site
  • Hyderabad, India, 500018
    • Research Site
  • Kolkatta, India, 700027
    • Research Site
  • Lucknow, India, 226003
    • Research Site
  • Maharashtra, India, 411013
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  • Mumbai, India, 400008
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  • Mysore, India, 570004
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  • Nadiad, India, 387001
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  • New Delhi, India, 110017
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  • New Delhi, India, 110060
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  • Pune, India, 411001
    • Research Site
  • Vellore, India, 632004
    • Research Site
  • Vijayawada, India, 520 008
    • Research Site
• Mexico
  • Aguascalientes, Mexico, 20219
    • Research Site
  • Guadalajara, Mexico, 44670
    • Research Site
  • Mexico, Mexico, 06700
    • Research Site
  • Veracruz, Mexico, 91900
    • Research Site
• Peru
  • Lima, Peru, L27
    • Research Site
  • Lima, Peru, 14
    • Research Site
  • Lima, Peru, LIMA 01
    • Research Site
• Philippines
  • Cebu City, Philippines, 6000
    • Research Site
  • Iloilo, Philippines, 5000
    • Research Site
  • Iloilo City, Philippines, 5000
    • Research Site
• Poland
  • Ciechanów, Poland, 06-400
    • Research Site
  • Katowice, Poland, 40-752
    • Research Site
  • Końskie, Poland, 26-200
    • Research Site
  • Pszczyna, Poland, 43-200
    • Research Site
  • Suwałki, Poland, 16-400
    • Research Site
  • Tarnów, Poland, 33-100
    • Research Site
  • Warszawa, Poland, 02-758
    • Research Site
  • Łódź, Poland, 90-153
    • Research Site
  • Łódź, Poland, 92-213
    • Research Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163001
    • Research Site
  • Barnaul, Russian Federation, 656024
    • Research Site
  • Irkutsk, Russian Federation, 664049
    • Research Site
  • Izhevsk, Russian Federation, 426035
    • Research Site
  • Kemerovo, Russian Federation, 650066
    • Research Site
  • Moscow, Russian Federation, 105229
    • Research Site
  • Moscow, Russian Federation, 123182
    • Research Site
  • Nizhny Novgorod, Russian Federation, 603126
    • Research Site
  • Penza, Russian Federation, 440034
    • Research Site
  • Perm, Russian Federation, 614000
    • Research Site
  • Pyatigorsk, Russian Federation, 357500
    • Research Site
  • Ryazan, Russian Federation, 390027
    • Research Site
  • Saint Petersburg, Russian Federation, 191015
    • Research Site
  • Ufa, Russian Federation, 450071
    • Research Site
• Slovakia
  • Banska Bystrica, Slovakia
    • Research Site
  • Banska Bystrica, Slovakia, 97517
    • Research Site
  • Bratislava, Slovakia, 82606
    • Research Site
  • Bratislava, Slovakia, 831 03
    • Research Site
  • Kosice, Slovakia, 04011
    • Research Site
  • Kralovsky Chlmec, Slovakia, 077 01
    • Research Site
  • Nove Zamky, Slovakia, 940 34
    • Research Site
  • Zvolen, Slovakia, 960 01
    • Research Site
• Spain
  • Almería, Spain, 04009
    • Research Site
  • Barcelona, Spain, 08029
    • Research Site
  • Granollers (Barcelona), Spain, 08400
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Sevilla, Spain, 41013
    • Research Site
  • Sevilla, Spain, 41071
    • Research Site
  • Tarragona, Spain, 43007
    • Research Site
  • Valencia, Spain, 46017
    • Research Site
• Sweden
  • Karlstad, Sweden, 651 85
    • Research Site
  • Stockholm, Sweden, 141 86
    • Research Site
  • Uppsala, Sweden, 751 85
    • Research Site
  • Västerås, Sweden, 721 89
    • Research Site
• Thailand
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • Research Site
  • Dnipro, Ukraine, 49005
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76018
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76008
    • Research Site
  • Kyiv, Ukraine, 01601
    • Research Site
  • Kyiv, Ukraine, 02125
    • Research Site
  • Kyiv, Ukraine, 04050
    • Research Site
  • Kyiv, Ukraine, 04107
    • Research Site
  • Odesa, Ukraine, 65025
    • Research Site
  • Odesa, Ukraine, 65074
    • Research Site
  • Poltava, Ukraine, 36024
    • Research Site
  • Ternopil, Ukraine, 46002
    • Research Site
  • Uzhhorod, Ukraine, 88006
    • Research Site
  • Vinnytsia, Ukraine, 21018
    • Research Site
  • Zaporizhzhya, Ukraine, 69001
    • Research Site
  • Zaporizhzhya, Ukraine, 69118
    • Research Site
  • Zaporizhzhya, Ukraine, 69600
    • Research Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Research Site
  • California
    • El Centro, California, United States, 92243
      • Research Site
    • Fairfield, California, United States, 94534
      • Research Site
    • Glendale, California, United States, 91205
      • Research Site
    • Long Beach, California, United States, 90807
      • Research Site
    • Long Beach, California, United States, 90802
      • Research Site
    • Los Angeles, California, United States, 90025
      • Research Site
    • Los Angeles, California, United States, 90022
      • Research Site
    • Lynwood, California, United States, 90262
      • Research Site
    • Northridge, California, United States, 91324
      • Research Site
    • Ontario, California, United States, 91762
      • Research Site
    • Orange, California, United States, 92868
      • Research Site
    • Riverside, California, United States, 92503
      • Research Site
    • Sacramento, California, United States, 95825
      • Research Site
    • Sun Valley, California, United States, 91352
      • Research Site
    • Whittier, California, United States, 90606
      • Research Site
    • Whittier, California, United States, 90602
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80230
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Research Site
  • Florida
    • Miami Gardens, Florida, United States, 33169
      • Research Site
  • Illinois
    • River Forest, Illinois, United States, 60305
      • Research Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Research Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Research Site
  • Maryland
    • Lanham, Maryland, United States, 20706
      • Research Site
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • Research Site
  • Michigan
    • Roseville, Michigan, United States, 48066
      • Research Site
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Research Site
  • Nevada
    • Reno, Nevada, United States, 89511
      • Research Site
  • New Jersey
    • Paterson, New Jersey, United States, 07504
      • Research Site
  • New York
    • Bronx, New York, United States, 10461
      • Research Site
    • Great Neck, New York, United States, 11021
      • Research Site
    • Orchard Park, New York, United States, 14127
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28805
      • Research Site
    • Charlotte, North Carolina, United States, 28207
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • Research Site
  • Oklahoma
    • Shawnee, Oklahoma, United States, 74804
      • Research Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19106
      • Research Site
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Research Site
  • Texas
    • Austin, Texas, United States, 78758
      • Research Site
    • Austin, Texas, United States, 78756
      • Research Site
    • Houston, Texas, United States, 77004
      • Research Site
    • Houston, Texas, United States, 77091
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 78212
      • Research Site
    • San Antonio, Texas, United States, 78222
      • Research Site
  • Virginia
    • Newport News, Virginia, United States, 23605
      • Research Site
    • Sterling, Virginia, United States, 20164
      • Research Site
  • West Virginia
    • Bluefield, West Virginia, United States, 24701
      • Research Site
• Vietnam
  • Can Tho, Vietnam, 900000
    • Research Site
  • Hanoi, Vietnam, 100000
    • Research Site
  • Hochiminh, Vietnam, 700000
    • Research Site
  • Hue, Vietnam, 530000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Provision of Informed Consent prior to any study specific procedures
2. Age ≥18 years at screening visit 1

3. 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.

4. 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.
5. Ferritin ≥100 ng/mL at randomization (obtained from screening visit)
6. TSAT ≥20% at randomization (obtained from screening visit)
7. Serum folate level ≥ lower limit of normal (LLN) at randomization (obtained from screening visit)
8. Serum vitamin B12 level ≥ LLN at randomization (obtained from screening visit)
9. 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)
10. Body weight 45 to 160 kg (prescribed dry weight)

Exclusion criteria:

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Previous randomisation in the present study
3. New York Heart Association Class III or IV congestive heart failure at enrolment
4. 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
5. History of chronic liver disease (e.g., chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis or fibrosis of the liver)
6. 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
7. Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis)
8. 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.
9. 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)
10. 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.
11. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
12. 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
13. Known hemosiderosis, hemochromatosis or hypercoagulable condition
14. 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
15. Any red blood cell (RBC) transfusion during the screening period
16. Any current condition leading to active significant blood loss
17. Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
18. 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 the month preceding 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)
19. History of alcohol or drug abuse within 2 years prior to randomization
20. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence (see Section 3.8)
21. Pregnant or breastfeeding females
22. Known allergy to the investigational product or any of its ingredients
23. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Roxadustat	Drug: Roxadustat; 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.
ACTIVE_COMPARATOR: Epoetin alfa	Drug: Epoetin alfa; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 36,without having received rescue therapy within 6 weeks prior to and during this 8 week evaluation period was analysed using Mixed Model of Repeated Measures (MMRM). Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 36 are presented for participants that did not receive rescue therapy within 6 weeks prior to and during this 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	The proportion of total time was computed as follows: For each participant, the recorded Hb values were first linearly interpolated between measurements. The time this interpolated curve was >=10 g/dL was computed and subsequently divided by the time between the measurements from Week 28 to Week 52. The difference between roxadustat and epoetin alfa were compared using ANCOVA. Baseline Hb was used as a covariate and the treatment groups, CV history, geographic region and dialysis duration as fixed effects.	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	The proportion of total time was computed as follows: For each participant, the recorded Hb values were first linearly interpolated between measurements. The time this interpolated curve was within 10-12 g/dL was computed and subsequently divided by the time between the measurement from Week 28 to 52. The difference between roxadustat and epoetin alfa were compared using ANCOVA. Baseline Hb was used as a covariate and the treatment groups, CV history, geographic region and dialysis duration as fixed effects.	Week 28 to 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 analysed using ANCOVA. Baseline Hb and baseline LDL were used as covariates and treatment groups, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented.	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 hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb is defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Changes in Hb from baseline to mean value during Weeks 28 to 52 in participants with baseline hsCRP >ULN was analyzed using a MAR based multiple imputation ANCOVA. Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 52 are presented.	Baseline (Day 1, Week 0), Week 28 to 52
Mean Monthly IV Iron Use From Week 36 to End of Study (EOS)	Oral iron supplementation was allowed for both treatment groups without restriction. Oral iron was recommended for dietary supplementation to support erythropoiesis and as the first line treatment for prevention and treatment of iron deficiency, unless the participant was intolerant to this route of treatment. In participants receiving roxadustat, the Investigator was allowed to initiate the use of an approved IV iron supplement if a participant's Hb value had not sufficiently responded to 2 or more dose increases of the IP, and ferritin <100 nanogram per milliliter (ng/mL) or transferrin saturation (TSAT) <20%. IP treatment was allowed to continue during IV iron administration. Discontinuation of IV iron supplementation was recommended once the participant was no longer considered to be iron deficient (ferritin >100 ng/mL and TSAT >20%).	Week 36 to EOS (4 weeks after the treatment period)
Time-To-First Administration of RBC Transfusion as Rescue Therapy	Time-to-first RBC transfusion as rescue therapy was calculated as (date of first occurrence of any RBC transfusion as rescue therapy, or date of censoring if no event had occurred) - (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.	Baseline (Day 1, Week 0) up to EOS (4 weeks after the treatment period)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: FibroGen
• Investigators: Study Director: Mark Houser, MD, AZ R&D, Gaithersburg, USA

Publications and helpful links

General 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.
• Fishbane 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.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): September 26, 2018
• Study Completion (ACTUAL): September 26, 2018

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (ESTIMATE): June 25, 2014

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: anemia; Renal,; CKD,; Roxadustat,; Epoetin alfa,; dialysis,
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: D5740C00002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No