Abstract: FR-OR106
Vadadustat Three Times Weekly for the Treatment of Anemia in Patients Receiving Hemodialysis
Session Information
- High-Impact Clinical Trials
October 23, 2026 | Location: Bluebird Ballroom, Convention Center
Abstract Time: 12:00 PM - 12:15 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Anand, Shuchi, University of California Davis, Davis, California, United States
- Chertow, Glenn M., Stanford University, Stanford, California, United States
- Wolf, Myles, Weill Cornell Medicine, New York, New York, United States
- Dittrich, Mary O., US Renal Care Inc, Plano, Texas, United States
- Green, Gopa, US Renal Care Inc, Plano, Texas, United States
- Block, Martha, US Renal Care Inc, Plano, Texas, United States
- Elorriaga, Adrian E., US Renal Care Inc, Plano, Texas, United States
- Brillhart, Stephanie, US Renal Care Inc, Plano, Texas, United States
- Leppink, Amanda, US Renal Care Inc, Plano, Texas, United States
- Newby, F. David, Nephrology and Hypertension Specialists, Dalton, Georgia, United States
- Arias, Carolina, South Texas Renal Care Group, San Antonio, Texas, United States
- Erinle, Ayodele, High Desert Nephrology Associates, Gallup, New Mexico, United States
- Agha, Irfan, Dallas Renal Group, Dallas, Texas, United States
- Block, Geoffrey A., US Renal Care Inc, Plano, Texas, United States
Background
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved for daily use among patients with end-stage kidney disease. Observed three-times weekly in-center vadadustat (TIW-V) administration may offer clinical and operational benefits.
Methods
In this 1:1 randomized, active-control, pragmatic trial conducted across 161 HD facilities we evaluated whether TIW-V was non-inferior to standard of care (SOC) epoetin alfa. The primary composite endpoint was the unmatched hierarchical win-odds of all-cause mortality and all-cause hospitalization on treatment +28-day window. Secondary outcomes included the individual components of the hierarchical composite endpoint. We identified events using electronic health records; investigators reviewed all hospitalizations. Management of anemia was directed by the treating nephrologist.
Results
Enrollment began in Nov 2024. 2,116 adult patients were randomized and 1,973 had at least one dose of study medication (n=943 TIW-V and n=1030 SOC). Baseline characteristics were similar between treatment groups. The mean weekly dose and duration of exposure was 2179 mg and 33 weeks for TIW-V, and 104 U/kg and 54 weeks for SOC. The study was terminated in June 2026 when a pre-specified interim analysis met the superiority criterion (Figure 1). The win-difference was 7.56% (2.9–12.3%) overall; –0.5% for mortality, and 8.1% for hospitalization. The incidence rate ratio (IRR) for mortality was 1.00 (0.72–1.39, p=0.98) and for hospitalization IRR was 0.90 (0.82–0.99, p=0.03). Mean hemoglobin over time was similar between groups. TIW-V-treated patients were less likely to experience hemoglobin >12 g/dL, odds ratio (OR) 0.36 (0.29, 0.44). Serious adverse events occurred in 42% (122 events/100PY) of TIW-V treated patients and 55% of SOC patients (134 events/100PY).
Conclusion
In this pragmatic trial embedding patient-level randomization in routine dialysis care, TIW-V administration was superior to SOC-EPO for the hierarchical composite endpoint of all-cause of death and hospitalization.
Acknowledgment
The authors would like to acknowledge the contributions of the VOICE investigators, USRC Kidney Research, US Renal Care and Satellite Heathcare[GG1] facility staff and operators, David Petterson Rush (Educator and Patient Advocate, US Renal Care), the American Association of Kidney Patients (AAKP), and the courageous patient volunteers contributing to this trial. Funding for this trial was provided by Akebia Therapeutics.
Funding
- Commercial Support – Akebia Therapeutics