Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience

Description

This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.

Trial Eligibility

Inclusion Criteria: * Adult patients greater than or equal to 18 years of age. * Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease. * Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy * Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure. Exclusion Criteria: * Contraindication to receive vadadustat or any of its known constituents per USPI. * Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide). * Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study. * Pregnant at time of consent (per subject self-report).

Study Info

Interventions

Locations Recruiting

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