Trials / Completed
CompletedNCT02021318
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 616 (actual)
- Sponsor
- Astellas Pharma Europe B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roxadustat | Oral tablet. |
| DRUG | Darbepoetin alfa | Subcutaneous or intravenous injection. |
Timeline
- Start date
- 2014-03-12
- Primary completion
- 2018-03-23
- Completion
- 2019-11-06
- First posted
- 2013-12-27
- Last updated
- 2024-11-14
- Results posted
- 2021-03-29
Locations
125 sites across 26 countries: Austria, Belarus, Bulgaria, Croatia, Czechia, Finland, France, Georgia, Germany, Hungary, Ireland, Israel, Latvia, Montenegro, Netherlands, North Macedonia, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02021318. Inclusion in this directory is not an endorsement.