At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 117 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 Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects With Chronic Kidney Disease Not Requiring Dialysis
In Brief
A Phase 2 clinical trial evaluating Roxadustat and Placebo for Chronic Kidney Disease and Anemia. Completed, enrolled 117 participants across 34 sites.
Detailed Summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Anemia
CountriesUnited States
CollaboratorsAstellas Pharma Inc
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedSep 2008
Primary CompletionJun 2010
TodayJul 2026
First PostedSep 29, 2008
Enrollment StartNov 1, 2006
Primary CompletionJun 21, 2010
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.8 years ago
Interventions
Roxadustatdrug
Capsule
Placebodrug
Capsule