Anemia in Chronic Kidney Disease in Non-dialysis Patients Clinical Trial
Official title:
A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.
This was a phase 3, multicenter, randomized, open-label, active-controlled study. The study was planned to provide key efficacy and safety data for the approval of roxadustat in the treatment of anemia associated with CKD. Participants assigned to roxadustat treatment were administered roxadustat orally as a combination of tablets of different strengths. Participants assigned to darbepoetin alfa treatment were administered darbepoetin alfa subcutaneously or intravenously. The study consisted of 3 study periods: - Screening period: up to 6 weeks - Treatment period: 104 weeks - Follow-up period: 4 weeks until planned study end (end of year 2) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01887600 -
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis
|
Phase 3 |