At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
Roxadustat +2 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 2, Randomized, Open-Label, Dose Titration, Safety and Efficacy Study of FG-4592 for the Correction of Anemia in Newly Initiated Dialysis Patients Not on Erythropoiesis-Stimulating Agent Treatment
In Brief
A Phase 2 clinical trial evaluating Roxadustat, Oral Iron, and 1 other intervention for Dialysis and Anemia. Completed, enrolled 60 participants across 7 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong, Russia, Singapore, United States
CollaboratorsAstellas Pharma Inc
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedAug 2011
Primary CompletionJan 2013
TodayJul 2026
First PostedAug 11, 2011
Enrollment StartJul 21, 2011
Primary CompletionJan 10, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.9 years ago
Interventions
Roxadustatdrug
Tiered, weight-based dosing per schedule specified in the arm.
Oral Irondrug
Administered per oral dose and schedule specified in the arm.
IV Irondrug
Administered per IV dose and schedule specified in the arm.