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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
What they're measuring
1
Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization.