CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 161 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.

Search/NCT01147666
NCT01147666Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) and Single-Blind Placebo-Controlled, Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis

Kyntra Bio·interventional·Posted Jun 22, 2010·Updated Jan 11, 2022

In Brief

A Phase 2 clinical trial evaluating Roxadustat, Epoetin Alfa, and 1 other intervention for End Stage Renal Disease and Anemia. Completed, enrolled 161 participants across 25 sites.

Detailed Summary

The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease, Anemia
CountriesUnited States
CollaboratorsAstraZeneca, Astellas Pharma Inc

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartMay 17, 2010
Primary CompletionOct 15, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.0 years ago

Interventions

Roxadustatdrug

Roxadustat will be administered per dose and schedule specified in the arms.

Epoetin Alfadrug

Epoetin Alfa will be administered per dose and schedule specified in the arms.

Placeboother

Placebo matching to roxadustat will be administered per schedule specified in the arm.