Vadadustat Matches ESA in Anemia Trial
Akebia Therapeutics reported phase 3 VOCAL results showing three-times-weekly oral vadadustat met noninferiority to an erythropoiesis-stimulating agent for hemoglobin maintenance.
Updated on Nov. 5, 2026 in Stroke
Akebia Therapeutics announced topline results from the phase 3 VOCAL trial, in which oral vadadustat dosed three times weekly achieved noninferiority to an ESA in maintaining hemoglobin levels in adults with anemia of chronic kidney disease. The open-label trial enrolled 353 adults receiving outpatient in-center hemodialysis.
Why it matters
The result suggests a possible oral alternative to injectable ESA therapy for dialysis patients managing anemia. Dosing frequency and administration route are central to treatment adherence and dialysis-center workflows.
The phase 3 VOCAL trial randomized 353 adults 1:1 and measured a least squares mean hemoglobin difference of -0.45 g/dL versus the ESA comparator, with a 95% confidence interval of -0.71 to -0.19 that stayed within the prespecified noninferiority margin of -0.75 g/dL. Longer-term outcomes beyond the weeks 20 to 24 primary endpoint window were not included in the extraction.
The players
Akebia Therapeutics
Akebia Therapeutics is a biopharmaceutical company focused on kidney disease, and it markets vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
The details
Participants were randomly assigned 1:1 to receive oral vadadustat three times weekly or methoxy polyethylene glycol-epoetin beta. The primary endpoint was the mean change in hemoglobin between baseline and the average of weeks 20 to 24.
Timeline
November 5, 2026: Akebia Therapeutics announced VOCAL trial topline results.
October 26, 2026: US Renal Care presented VOICE trial analysis at ASN Kidney Week.
Weeks 20 to 24: Average hemoglobin measured for the primary endpoint.
Health Landscape
The TIW dosing result extends the once-daily Vafseo approval for anemia due to chronic kidney disease into a dialysis-schedule context. It shifts the treatment conversation from daily oral dosing toward regimens aligned with in-center hemodialysis sessions.
Three-times-weekly oral dosing could fit within existing in-center hemodialysis schedules rather than requiring daily home administration. Patients and clinicians would still need the final regulatory labeling for the TIW regimen before any change in care.
The takeaway
Oral vadadustat dosed three times weekly matched an ESA on hemoglobin maintenance in this trial, a result that could widen anemia treatment options for dialysis patients. Readers managing kidney disease should confirm current labeling with their care team.
Further reading
For more on related cardiovascular and kidney-linked conditions, see Stroke.
