At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 616 enrolled
Drug / intervention
Roxadustat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Roxadustat and Darbepoetin alfa for Anemia in Chronic Kidney Disease in Non-dialysis Patients. Completed, enrolled 616 participants across 125 sites in 26 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, 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
CollaboratorsKyntra Bio
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartMar 2014
Primary CompletionMar 2018
Study CompletionNov 2019
TodayJul 2026
First PostedDec 27, 2013
Enrollment StartMar 12, 2014
Primary CompletionMar 23, 2018
Study CompletionNov 6, 2019
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 12.5 years ago
Interventions
Roxadustatdrug
Oral tablet.
Darbepoetin alfadrug
Subcutaneous or intravenous injection.