Abstract: FR-PO0204
Vadadustat Outcomes In-Center Experience (VOICE) Study: Pragmatic Randomized Controlled Trial to Test the Safety of Three Times Weekly Vadadustat
Session Information
- Anemia and Iron Metabolism
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Block, Geoffrey A., US Renal Care, Plano, Texas, United States
- Anand, Shuchi, Stanford University, Stanford, California, United States
- Green, Gopa B., US Renal Care, Plano, Texas, United States
Group or Team Name
- VOICE Study Group.
Background
Vadadustat was FDA approved for daily use in 2024 to treat anemia in patients receiving dialysis. Three times weekly (TIW) administration may offer clinical and operational benefits, but its long-term safety data are limited.
Methods
This randomized controlled trial is testing whether TIW vadadustat is non-inferior to epoetin alfa on the primary hierarchical outcome of all-cause mortality and all-cause hospitalization analyzed using the win ratio (NCT06520826). The trial relies on a centralized infrastructure: patient-level consent obtained by trained dialysis staff; medication titration by existing anemia managers; primary and key secondary outcomes data ascertained through the electronic health record; and a streamlined supplemental electronic data capture system to support adverse event adjudication and oversight by a small investigator team.
Results
As of May 2025, 1806 patients have been randomized across 161 nationwide facilities (median n of patients enrolled per facility = 9, Figure 1). With a sample size of 1800 and estimated 20% dropout, the trial has 90% power show non-inferiority (margin 1.25) of vadadustat relative to epoetin alfa on the primary hierarchical outcome. By Kidney Week, baseline characteristics by study arm for the fully enrolled cohort will be available, and longitudinal hemoglobin concentrations will be available.
Conclusion
The VOICE trial design showcases a pragmatic approach to embed individual-level randomized clinical trials in routine dialysis care. The trial will generate critical data on the safety of a new anemia management strategy while leveraging a composite hierarchical outcome to optimize statistical efficiency and clinical relevance.
Funding
- Commercial Support – Akebia Therapeutics Inc