A Clinical Trial Program Enrolling Patients with Dialysis-Dependent and Non-Dialysis-Dependent CKD
The safety and efficacy of vadadustat have been studied in 15 completed clinical studies, including 10 Phase 1 studies (9 in healthy volunteers and 1 in subjects undergoing chronic hemodialysis) and 5 Phase 2 studies in patients with NDD-CKD and DD-CKD.
Vadadustat Phase 3 Program for the Treatment of Anemia Associated With CKD
Randomized, Open-Label, Active-Controlled, Non-Inferiority Phase 3 Cardiovascular Outcomes Studies
Vadadustat is currently being evaluated in four Phase 3 pivotal studies in patients with anemia associated with chronic kidney disease (CKD). Each of the 4 studies features a randomized, open-label, active control (darbepoetin alfa), non-inferiority design.
Additionally, Akebia has initiated the Phase 2 FO2RWARD study of vadadustat in dialysis-dependent patients who are hyporesponsive to ESAs. FO2RWARD is a randomized, open-label study that will assess the safety and efficacy of vadadustat versus epoetin alfa in approximately 50 DD-CKD patients with ESA hyporesponse in the United States. The primary outcome measure will be the change in hemoglobin from baseline over time during the treatment period.
Akebia will initiate the TRILO2GY study to evaluate three-times weekly dosing of vadadustat in patients with DD-CKD. This study is designed to confirm earlier results, which demonstrated that dialysis-dependent patients receiving oral vadadustat three times per week maintained stable hemoglobin levels following conversion from erythropoiesis-stimulating agent (ESA) therapy.
Learn more about our ongoing clinical programs: www.clinicaltrials.gov
If you would like to learn more about our clinical trials, including becoming a participating investigator or referring physician, please email email@example.com.
Vadadustat is an investigational drug and has not yet been approved by the US Food and Drug Administration (FDA) or any regulatory authority.