Akebia: VOICE trial stopped early after vadadustat shows superiority on primary composite endpoint

Akebia reported that a planned interim analysis of the VOICE trial met stopping criteria, showing non-inferiority and superiority of Vafseo on the primary composite endpoint (win odds 1.16, p=0.0016).Key Highlights:Original SEC Filing: Akebia Therapeutics, Inc. [ AKBA ] - 8-K - Jun. 30, 2026This is…

Akebia reported that a planned interim analysis of the VOICE trial met stopping criteria, showing non-inferiority and superiority of Vafseo on the primary composite endpoint (win odds 1.16, p=0.0016).

Key Highlights:

VOICE interim analysis (data cutoff June 1, 2026) met prespecified stopping criteria with win odds 1.16 (95% CI 1.06–1.28; p=0.0016).
Primary composite endpoint (all-cause mortality and hospitalization) showed superiority, driving decision to stop the trial.
Hospitalizations decreased with Vafseo vs ESA: 1.11 vs 1.23 per patient-year; incidence rate ratio 0.90 (95% CI 0.824–0.988).
No significant difference in mortality: 8.77% vs 8.78% per 100 patient-years; incidence rate ratio 1.00 (95% CI 0.718–1.391).
VOICE enrolled 2,116 patients; trial was randomized, open-label, active-controlled, investigator-initiated by U.S. Renal Care.

Original SEC Filing:

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