At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,043 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, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients
In Brief
A Phase 3 clinical trial evaluating Roxadustat and Epoetin Alfa for Anemia in Incident Dialysis Patients. Completed, enrolled 1,043 participants across 113 sites in 15 countries.
Detailed Summary
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia in Incident Dialysis Patients
CountriesArgentina, Bulgaria, Chile, Colombia, Latvia, Malaysia, Mexico, Poland, Romania, Russia, South Korea, Taiwan, Thailand, Ukraine, United States
CollaboratorsAstellas Pharma Europe B.V., AstraZeneca
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartFeb 2014
Primary CompletionSep 2018
TodayJul 2026
First PostedFeb 3, 2014
Enrollment StartFeb 11, 2014
Primary CompletionSep 21, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.4 years ago
Interventions
Roxadustatdrug
Roxadustat will be administered per dose and schedule specified in the arm.
Epoetin Alfadrug
Epoetin alfa will be administered TIW according to the epoetin alfa USPI or SmPC, or local SOC.