Akebia Therapeutics, Inc. Announces Vadadustat U.S. Patient Data from Global Phase 3 Clinical Program Published in Journal of the American Society of Nephrology
AKBA
Published on 06/04/2025 at 09:05
Akebia Therapeutics®?, Inc. announced that the Journal of the American Society of Nephrology (JASN) has published pre-specified analyses for the U.S. and non-U.S. patient subgroups from the vadadustat global phase 3 clinical program, which included two trials in patients with dialysis-dependent chronic kidney disease (DD-CKD; INNO2VATE) and two trials in patients with non-dialysis-dependent CKD (NDD-CKD; PRO2TECT). The vadadustat global Phase 3 clinical trials were open-label, randomized, noninferiority trials that compared the safety and efficacy of vadadustat with darbepoetin alfa in adult patients with CKD-related anemia. Data from the pre-specified analyses for the US.
patient subgroup demonstrate that among patients with DD-CKD, safety and efficacy of vadADustat and darbepoetin Alfa in the U.S. and outside the U.S. were similar. Vafseo®? (vadadustat) was approved by the U.S. Food and Drug Administration in March 2024 for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months.
Vafseo has been available in the U.S. since January 2025. Full results of the vadadust at global clinical phase 3 clinical program were previously published in the New England Journal of Medicine: INNOVATE, PRO,TECT. The Journal of the American Society ofrology, an official publication of the American Society of Nephrol (ASN), publishes high-impact research to advance the understanding and treatment of kidney diseases, includingiology, pathobiology, and person-centered care.
In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetinAlfa.