Vafseo Outcomes In-Center Experience (VOICE)

USRC Kidney Research

Status and phase: Enrolling; Phase 3

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Vadadustat; Drug: Erythropoiesis Stimulating Agent

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT06520826

USRC-2024-001

Details and patient eligibility

About

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.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,200 participants in 2 patient groups

Vadadustat

Experimental group

Description:

Vadadustat, 300 mg tablets, administered orally three times per week

Treatment:

Drug: Vadadustat

Erythropoiesis-stimulating agent (ESA) - Standard of Care (SOC)

Active Comparator group

Description:

Epoetin alfa (EPOGEN), Methoxy polyethylene glycol-epoetin beta (Mircera), or Darbepoetin alfa (Aranesp) administered as per standard of care

Treatment:

Drug: Erythropoiesis Stimulating Agent