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Completed NCT06901505

To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis

Conditions: Anemia of Chronic Kidney Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 353
Sponsor: Akebia Therapeutics

Location: DaVita Research Site Montgomery Alabama

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06901505). StuddyBuddy aggregates publicly available trial information.