Akebia Therapeutics Announces Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis

The INNO2VATE program (Correction/Conversion and Conversion studies) of dialysis patients (n=3,902):

  • Vadadustat was non-inferior to darbepoetin alfa. The upper bound of the 95% confidence interval (CI) of the Hazard Ratio (HR) was below the pre-specified non-inferiority margin of 1.25 for primary MACE analysis. (HR 0.96, 95% CI: 0.83, 1.11.) MACE is defined as the composite endpoint of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke.

The incidence of treatment emergent adverse events during the Correction/Conversion study in vadadustat treated patients was 83.8% and 85.5% in darbepoetin alfa treated patients. During the study, the most common treatment emergent adverse events reported in vadadustat/darbepoetin alfa treated patients were hypertension (16.2%/ 12.9%) and diarrhea (10.1%/ 9.7%). Serious treatment emergent adverse events were lower in vadadustat treated patients at 49.7% compared to 56.5% for darbepoetin alfa treated patients. The incidence of treatment emergent adverse events during the Conversion study in the vadadustat treated patients was 88.3%, and 89.3% in darbepoetin alfa treated patients. During the study, the most common treatment emergent adverse events reported in vadadustat/darbepoetin alfa treated patients were diarrhea (13.0%/ 10.1%), pneumonia (11.0%/ 9.7%), hypertension (10.6%/ 13.8%), and hyperkalemia (9.0%/ 10.8%). Serious treatment emergent adverse events were slightly lower for vadadustat treated patients at 55.0% and 58.3% for darbepoetin alfa-treated patients.

“With nearly 4,000 patients participating in INNO2VATE and a total exposure of just over 2,200 patient-years with vadadustat, INNO2VATE has been a tremendous undertaking. We would like to extend our sincere thanks to everyone involved in this study including the patients, physicians, investigators and site coordinators,” said Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia. “We believe vadadustat has the potential to play a key role in the treatment of anemia due to CKD, and we are another step closer to realizing that vision. We are very pleased with these clear and consistent findings and are excited to share the full data set, together with the data from our PRO2TECT studies, later this year at a medical conference and in a peer-reviewed journal.”

1 2 3 4 5 6 7 8 9

Share