At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,133 enrolled
Drug / intervention
Roxadustat +1 moredrug
Likely dose
Roxadustat 11 gfrom 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, Multicenter, Randomized, Open-label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients
In Brief
A Phase 3 clinical trial evaluating Roxadustat and Epoetin alfa for Anemia. Completed, enrolled 2,133 participants across 188 sites in 18 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesAustralia, Bulgaria, Canada, Czechia, Hungary, India, Mexico, Peru, Philippines, Poland, Russia, Slovakia, Spain, Sweden, Thailand, Ukraine, United States, Vietnam
CollaboratorsKyntra Bio
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJul 2014
Primary CompletionSep 2018
TodayJul 2026
First PostedJun 25, 2014
Enrollment StartJul 1, 2014
Primary CompletionSep 26, 2018
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.0 years ago
Interventions
Roxadustatdrug
Roxadustat will be administered orally three times a week (TIW) to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.
Epoetin alfadrug
Epoetin alfa will be administered TIW consistent with approved prescribing information for epoetin alfa to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.