Additional Relevant Details
The INNO2VATE program includes two separate studies and will collectively enroll approximately 2,600 dialysis-dependent patients with anemia related to chronic kidney disease. Both studies will include a 1:1 randomization and an open label, active-control, non-inferiority design. Primary endpoints include an efficacy assessment of the hemoglobin response and an assessment of cardiovascular safety as measured by standard major adverse cardiovascular events (MACE) criteria. The INNO2VATE-Correction study will evaluate patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The INNO2VATE-Conversion study will evaluate patients currently receiving rESA who will be converted to either vadadustat or the active control, with the goal of maintaining their baseline hemoglobin levels.