At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 741 enrolled
Drug / intervention
Epoetin Alfa +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, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis
In Brief
A Phase 3 clinical trial evaluating Epoetin Alfa and Roxadustat for CKD Anemia in Stable Dialysis Patients. Completed, enrolled 741 participants across 76 sites in 2 countries.
Detailed Summary
The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCKD Anemia in Stable Dialysis Patients
CountriesPuerto Rico, United States
CollaboratorsAstellas Pharma Europe B.V., AstraZeneca
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartJan 2015
Primary CompletionSep 2018
TodayJul 2026
First PostedOct 24, 2014
Enrollment StartJan 15, 2015
Primary CompletionSep 19, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.7 years ago
Interventions
Epoetin Alfadrug
Epoetin alfa will be administered per dose and schedule specified in the arm.
Roxadustatdrug
Roxadustat will be administered per dose and schedule specified in the arm.