At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,781 enrolled
Drug / intervention
Roxadustat +1 moredrug
Likely dose
Roxadustat 70 mgfrom 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, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
In Brief
A Phase 3 clinical trial evaluating Roxadustat and Placebo for Anemia. Completed, enrolled 2,781 participants across 359 sites in 26 countries.
Detailed Summary
The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesArgentina, Brazil, Bulgaria, Canada, Colombia, Czechia, Germany, Hungary, India, Malaysia, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States, Vietnam
CollaboratorsKyntra Bio
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJun 2014
Primary CompletionOct 2018
TodayJul 2026
First PostedJun 25, 2014
Enrollment StartJun 26, 2014
Primary CompletionOct 4, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.0 years ago
Interventions
Roxadustatdrug
The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
Placebodrug
The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.