At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 456 enrolled
Drug / intervention
Vadadustat +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, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
In Brief
A Phase 3 clinical trial evaluating Vadadustat and Mircera® for Anemia Associated With Chronic Kidney Disease (CKD). Completed, enrolled 456 participants across 58 sites.
Detailed Summary
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartJun 2021
Primary CompletionJan 2023
Study CompletionJan 2023
TodayJul 2026
First PostedJan 13, 2021
Enrollment StartJun 18, 2021
Primary CompletionJan 6, 2023
Study CompletionJan 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.5 years ago
Interventions
Vadadustatdrug
oral tablets
Mircera®drug
intravenous administration