Vafseo Outcomes In-Center Experience

Running, not enrolling · Phase 3

Conditions studied: Anemia of Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT06520826

Run by

USRC Kidney Research

People needed

2200

Starts

2024-11-20

Expected to finish

2026-06-30

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• USRC Kidney Research — Lone Tree, Colorado, United States
• Nephrology and Hypertension Specialists, PC — Dalton, Georgia, United States
• US Renal Care - Gallup — Gallup, New Mexico, United States
• Dallas Renal Group — Dallas, Texas, United States
• US Renal Care - Live Oak — Live Oak, Texas, United States

Full record on ClinicalTrials.gov

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