Vafseo (vadadustat)(TIW) versus an erythropoiesis-stimulating agent (ESA). - (VOICE)

June 30, 2026: Akebia Therapeutics, Inc. (NASDAQ: AKBA) and U.S. Renal Care (USRC) announced USRC Kidney Research has stopped the Vafseo Outcomes In-Center Experience (VOICE) trial after a planned interim analysis, following recommendations from the Independent Data Monitoring Committee and Trial Steering Committee and per prespecified stopping criteria. VOICE evaluated Vafseo (vadadustat) dosed three times weekly (TIW) during in-center hemodialysis vs standard-of-care erythropoiesis-stimulating agents (ESAs) in U.S. patients with anemia due to CKD on dialysis.

At the June 1, 2026 data cutoff, the interim analysis of the hierarchical composite primary endpoint (all-cause mortality + hospitalization, win odds method) met non-inferiority and showed superiority: win odds 1.16 (95% CI 1.06–1.28; p=0.0016). Hospitalizations were significantly reduced with Vafseo vs ESA (1.11 vs 1.23 per patient-year; IRR 0.90 [95% CI 0.824–0.988]). Mortality rates were not significantly different (8.77% vs 8.78% per 100 patient-years; IRR 1.00 [95% CI 0.718–1.391]). The trial enrolled 2,116 patients. Akebia and USRC plan to submit the results for presentation at an upcoming scientific meeting.