Workflow
win-odds analysis
icon
Search documents
Vafseo® (vadadustat) Dialysis Dependent Patient Post Hoc Data Analysis: Composite of All-Cause Mortality and Hospitalization Outcomes Statistically More Favorable for Patients Receiving Vadadustat vs. ESAs
Globenewswire· 2025-11-06 23:30
Core Insights - Akebia Therapeutics presented a post-hoc win odds analysis at ASN Kidney Week 2025, showing that vadadustat (Vafseo) significantly reduces the risk of all-cause mortality and hospitalization compared to darbepoetin alfa in patients with CKD-related anemia undergoing dialysis [1][5][3] Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [7] - Vafseo (vadadustat) is approved for treating 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 [2][9] Study Details - The analysis was based on data from two global Phase 3, open-label, randomized noninferiority trials (INNO2VATE) comparing vadadustat to darbepoetin alfa in adults with anemia associated with dialysis-dependent CKD [4] - The primary safety endpoint was the time to first adjudicated major adverse cardiovascular events (MACE), which includes death from any cause, non-fatal myocardial infarction, or non-fatal stroke [4] Statistical Analysis - The win-odds analysis indicated that the composite of all-cause mortality and hospitalizations was statistically significantly lower for patients receiving vadadustat compared to those receiving darbepoetin alfa [5][6] - The inverted win-odds ratio for vadadustat was reported as 0.93 (95% CI 0.87-0.99; P=0.03) and 0.86 (95% CI 0.81-0.95; p <0.0001) for treatment plus 28 days post last dose [8] Future Directions - Akebia aims to make Vafseo the standard of care for CKD-related anemia in dialysis patients and is advancing multiple trials, including the VOICE trial, to measure mortality and hospitalizations in real-world settings [3][26]