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Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis — Pyrenees  

Anemia Clinical Trial

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 Patients on Stable Dialysis

Clinical Trial Summary

This study was conducted to explore a new therapy for anemia in participants 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 was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

Clinical Trial Description

This study consisted of three study periods as follows: - Screening Period: up to 6 weeks - Treatment Period: a minimum of 52 weeks up to a maximum of 104 weeks - Follow-up Period: 4 weeks ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02278341
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 3
Start date November 21, 2014
Completion date July 6, 2018
View Details
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