A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.
• Adult participants ≥18 years of age.
• Receiving outpatient in-center hemodialysis for ESKD at least three times a week.
• Currently prescribed or meets criteria for ESA based on approved facility policy.
• Hb \> 8 grams per deciliter (g/dl).
• Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20%.
• Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
• For selected sites, individuals who opt to participate in the RBC sub-study must meet the following inclusion criteria:
• Currently prescribed or will be prescribed methoxy polyethylene glycol-epoetin beta.
• Hb \<11.5 g/dL