CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Roxadustatdrug
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/NCT01630889
NCT01630889Phase 2Completed
CompareCT.gov

Open-Label Extension Study to Evaluate the Efficacy and Safety of FG-4592 for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients With Chronic Kidney Disease

Kyntra Bio·interventional·Posted Jun 28, 2012·Updated Oct 1, 2021

In Brief

A Phase 2 clinical trial evaluating Roxadustat for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 15 participants across 7 sites in 2 countries.

Detailed Summary

The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, End Stage Renal Disease, Anemia
CountriesPuerto Rico, United States
CollaboratorsAstraZeneca, Astellas Pharma Inc

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2012
Enrollment StartMay 18, 2012
Primary CompletionDec 12, 2019
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 14.0 years ago

Interventions

Roxadustatdrug

Oral capsule