Vadadustat Releases U.S. Patient Data From Global Phase 3 Clinical Program In Journal of the American Society Of Nephrology

Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today 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 U.S. 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. Among the U.S. patient subgroup with NDD-CKD, safety and efficacy outcomes were similar, but the risk for major adverse cardiovascular event (MACE) with vadadustat was higher than darbepoetin alfa outside the United States. In these analyses, safety was measured by time to first MACE and efficacy was measured by mean change in hemoglobin. The article titled, "Safety and Efficacy of Vadadustat for the Treatment of CKD-Related Anemia within and outside the United States," is available here.

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.

"Geographic-specific pre-specified analyses of the vadadustat global phase 3 clinical program are important data as physicians in the U.S. are making care decisions for patients with CKD-related anemia," said Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia. "The analyses reflect how regional differences in clinical trial patient baseline characteristics, hemoglobin targets, and access to health care services and other regional clinical practices can ultimately contribute to differing outcomes in a global trial."