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

Akebia Therapeutics

Status and phase: Not yet enrolling; Phase 3

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Vadadustat; Drug: Erythropoiesis-Stimulating Agent (ESA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06901505

VOCAL

AKB-6548-CI-0052

Details and patient eligibility

About

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). The total duration of the study is approximately 33 Weeks including screening and follow-up.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Contraindication to receive vadadustat per United States prescribing information (USPI) as determined by the treating health care provider.
• Concomitant use of any hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI).
• Known cirrhosis or active, acute liver disease.
• Unable to comply with study requirements or compliance with attending dialysis treatments as prescribed, or in the opinion of the treating physician or Investigator, not clinically stable to participate in the study.
• Pregnant at the time of consent (per participant self-report).
• Any other reason, which in the opinion of the Investigator, would make the participants unsuitable for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Vadadustat

Experimental group

Description:

Study drug will be administered three times a week.

Treatment:

Drug: Vadadustat

Erythropoiesis-Stimulating Agent (ESA)

Active Comparator group

Description:

Dose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per Davita's ESA dosing protocol

Treatment:

Drug: Erythropoiesis-Stimulating Agent (ESA)