At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 319 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.
Phase 3b, Randomized, Open-label, Active-controlled Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)
In Brief
A Phase 3 clinical trial evaluating Vadadustat and Darbepoetin alfa for Anemia. Completed, enrolled 319 participants across 59 sites in 6 countries.
Detailed Summary
This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesCzechia, Hungary, Italy, Poland, Spain, United States
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartMay 2020
Primary CompletionNov 2021
Study CompletionJun 2022
TodayJul 2026
First PostedMar 18, 2020
Enrollment StartMay 27, 2020
Primary CompletionNov 26, 2021
Study CompletionJun 22, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.3 years ago
Interventions
Vadadustatdrug
oral tablets
Darbepoetin alfadrug
intravenous or subcutaneous solution