Akebia completes enrollment in late-stage vadadustat program

Akebia Therapeutics (AKBA +1.9%) perks up, albeit on light volume, in reaction to its announcement that its Phase 3 program evaluating vadadustat in chronic kidney disease (CKD) patients with anemia is now fully enrolled.

The INNO₂VATE studies completed the enrollment of 3,923 dialysis-dependent CKD patients in April and the PRO₂TECT studies are now fully enrolled with 3,513 non-dialysis-dependent CKD patients.

The trials are assessing vadadustat compared to darbepoetin alfa. The primary endpoints are the change in hemoglobin from baseline at week 36 and safety (major adverse cardiovascular events).

Topline data from INNO₂VATE should be available in Q2 2020 followed by PRO₂TECT in mid-2020.

https://seekingalpha.com/news/3496373-akebia-completes-enrollment-late-stage-vadadustat-program