At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 203 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.
A Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From a Continuous Erythropoietin Receptor Activator (CERA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients - DENALI Study
In Brief
A Phase 3 clinical trial evaluating Roxadustat for Anemia Associated With End Stage Renal Disease (ESRD). Completed, enrolled 203 participants across 9 sites.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis participants converted from ESA therapy or who are ESA-naïve.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartMay 2020
First PostedJun 2020
Primary CompletionJun 2021
Study CompletionOct 2021
TodayJul 2026
First PostedJun 1, 2020
Enrollment StartMay 26, 2020
Primary CompletionJun 30, 2021
Study CompletionOct 11, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.1 years ago
Interventions
Roxadustatdrug
Roxadustat will be administered per dose and schedule specified in the arm description.