At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 283 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.
Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients
In Brief
A Phase 3 clinical trial evaluating Roxadustat for Anemia Associated With End Stage Renal Disease. Completed, enrolled 283 participants across 26 sites.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartJul 2020
First PostedJul 2020
Primary CompletionJul 2021
Study CompletionSep 2021
TodayJul 2026
First PostedJul 24, 2020
Enrollment StartJul 22, 2020
Primary CompletionJul 9, 2021
Study CompletionSep 17, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.9 years ago
Interventions
Roxadustatdrug
Roxadustat will be administered per dose and schedule specified in the arm description.