Akebia and USRC halt VOICE trial early after Vafseo beats ESA on safety

Akebia Therapeutics and U.S. Renal Care (USRC) said on June 30, 2026 that USRC Kidney Research halted the VOICE trial ahead of schedule based on a planned interim look at the data. The Primary Investigator made the call after the Independent Data Monitoring Committee and Trial Steering Committee recommended stopping, citing prespecified criteria and improved safety findings for patients on Vafseo (vadadustat) given three times weekly compared with an erythropoiesis-stimulating agent (ESA).¹

The study, known as the "Vafseo Outcomes In Center Experience (VOICE)" trial, was a randomized, open-label, active-controlled, non-inferiority study sponsored by USRC that enrolled 2,116 patients to compare safety of Vafseo dosed three times weekly against standard ESA therapy, using a hierarchical composite of mortality and hospitalization.¹

At the June 1, 2026 data cutoff, the interim analysis showed the trial met its stopping criteria with a win odds of 1.16 (95% CI 1.06 to 1.28, p=0.0016), establishing both non-inferiority and superiority on the primary composite endpoint.¹ On the hospitalization component, patients on Vafseo had fewer hospitalizations per patient year than those on ESA, 1.11 versus 1.23, corresponding to an incidence rate ratio of 0.90 (95% CI 0.824 to 0.988).¹ Mortality rates did not differ significantly between arms, at 8.77% versus 8.78% per 100 patient-years (incidence rate ratio 1.00, 95% CI 0.718 to 1.391).¹

A steering committee member, Stanford's Glenn Chertow, said the VOICE results using three-times-weekly dosing during hemodialysis closely matched a prior post-hoc analysis of the INNO2VATE program, which used daily home dosing.¹

Akebia and USRC said they plan to submit the data for presentation at an upcoming scientific meeting.¹ Vafseo was approved by the FDA in March 2024 for anemia due to chronic kidney disease in adults on dialysis for at least three months, and has been available in the U.S. since January 2025.¹