Clinical TrialJun 30, 2026, 08:11 AM
Akebia's Vafseo VOICE Trial Meets Stopping Criteria, Shows Superiority
AI Summary
Akebia Therapeutics and U.S. Renal Care announced that the Vafseo Outcomes In Center Experience (VOICE) trial met its predefined stopping criteria during a planned interim analysis. The trial demonstrated non-inferiority and superiority of Vafseo for the primary composite endpoint of all-cause mortality and hospitalization, leading to the decision to stop the trial early. Results showed a statistically significant reduction in hospitalizations with Vafseo compared to standard-of-care erythropoiesis stimulating agents (ESA).
Key Highlights
- VOICE trial met predefined stopping criteria for non-inferiority and superiority.
- Win odds of 1.16 (95% CI 1.06, 1.28, p=0.0016) for primary composite endpoint.
- Statistically significant decrease in hospitalizations with Vafseo (1.11 vs 1.23 per patient year).
- No statistically significant difference in mortality rates (8.77% vs 8.78%).
- Trial enrolled 2,116 patients measuring safety of Vafseo vs. ESA.
- Primary investigator decided to stop the trial based on interim analysis.
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