At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 922 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, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) 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 CKD Anemia. Completed, enrolled 922 participants across 145 sites in 16 countries.
Detailed Summary
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCKD Anemia
CountriesArgentina, Australia, Chile, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Peru, Philippines, Puerto Rico, Singapore, South Korea, Taiwan, Thailand, United States
CollaboratorsAstellas Pharma Europe B.V., AstraZeneca
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedDec 2012
Primary CompletionSep 2018
TodayJul 2026
First PostedDec 17, 2012
Enrollment StartNov 5, 2012
Primary CompletionSep 24, 2018
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.5 years ago
Interventions
Roxadustatdrug
Oral tablets
Placebodrug
Oral tablets