At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 175 enrolled
Drug / intervention
Vadadustat +2 moredrug
Likely dose
Vadadustat 150 mgfrom 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 2, Randomized, Open-Label, Active-Controlled, Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects Converting From Epoetin Alfa (FO2RWARD-2)
In Brief
A Phase 2 clinical trial evaluating Vadadustat, Epoetin Alfa, and 1 other intervention for Anemia and Dialysis-dependent Chronic Kidney Disease. Completed, enrolled 175 participants across 41 sites.
Detailed Summary
This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Dialysis-dependent Chronic Kidney Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartJan 2019
Primary CompletionJun 2020
Study CompletionJul 2020
TodayJul 2026
First PostedJan 10, 2019
Enrollment StartJan 31, 2019
Primary CompletionJun 5, 2020
Study CompletionJul 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.5 years ago
Interventions
Vadadustatdrug
Vadadustat Tablets 150 mg
Epoetin Alfadrug
Epoetin Alfa
Vadadustat TIWdrug
Oral Vadadustat