Overview

This trial is active, not recruiting.

Conditions anemia, end stage renal disease (esrd)
Treatments roxadustat, epoetin alfa, darbepoetin alfa
Phase phase 3
Sponsor Astellas Pharma Europe B.V.
Collaborator FibroGen
Start date November 2014
End date June 2017
Trial size 838 participants
Trial identifier NCT02278341, 1517-CL-0613, 2013-001497-16

Summary

This study is conducted to explore a new therapy for anemia in patients with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study is to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD patients on stable dialysis. Roxadustat will be compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose adjustments are allowed during the study.
roxadustat ASP1517
Oral Tablet
(Active Comparator)
Treatment administered can be epoetin alfa or darbepoetin alfa. Dose adjustments are allowed during the study.
epoetin alfa Eprex
Subcutaneous (SC) or Intravenous (IV) Injection
darbepoetin alfa Aranesp
Subcutaneous or Intravenous Injection

Primary Outcomes

Measure
EU (European Medicines Agency): Hemoglobin (Hb) change from baseline to the average Hb of weeks 28 to 36 without having received rescue therapy
time frame: Baseline and Weeks 28 to 36
US (Food and Drug Administration): Hemoglobin (Hb) change from baseline to the average Hb of weeks 28 to 52, regardless of rescue therapy
time frame: Baseline and Weeks 28 to 52

Secondary Outcomes

Measure
Hb response without having received rescue therapy
time frame: Weeks 28 to 36
Change from baseline in Low Density Lipoprotein (LDL) cholesterol to the average LDL cholesterol
time frame: Baseline and Weeks 12 to 28
Mean monthly intravenous (IV) iron use (mg)
time frame: Day 1 to Week 36
Blood pressure effect: Change from baseline in mean arterial pressure (MAP) to the average MAP value
time frame: Baseline and Weeks 20 to 28
Blood pressure effect: Time to an increase in blood pressure
time frame: Weeks 1 to 26
Change from baseline in SF-36 Physical Functioning (PF) sub-score to the average PF sub-score
time frame: Baseline and Weeks 12 to 28
Change from baseline in SF-36 Vitality (VT) sub-score to the average VT sub-score
time frame: Baseline and Weeks 12 to 28

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Main Inclusion: - Subject is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization. - Subject is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization). - Mean of the subject's three most recent Hb values, as measured by central laboratory, during the Screening Period. - Subject's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN. Exclusion Criteria: Main Exclusion: - Subject has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization. - Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD). - Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization. - Subject has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization. - Subject has a history of malignancy, except for 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. - Subject has had any prior organ transplant (that has not been explanted), or subject is scheduled for organ transplantation.

Additional Information

Official title A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Subjects on Stable Dialysis
Description This study will consist of three study periods as follows: - Screening Period: up to 6 weeks - Treatment Period: 104 weeks - Follow-up Period: 4 weeks
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.