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

Phase 3

Not yet recruiting

• Conditions: Anemia of Chronic Kidney Disease
• Interventions: Drug: Vadadustat; Drug: Erythropoiesis-Stimulating Agent (ESA)

• Registration Number: NCT06901505
• Lead Sponsor: Akebia Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-04
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vadadustat	Vadadustat	Study drug will be administered three times a week.
Erythropoiesis-Stimulating Agent (ESA)	Erythropoiesis-Stimulating Agent (ESA)	Dose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per Davita's ESA dosing protocol

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin (Hb)	Baseline and from Week 20 to Week 24

Secondary Outcome Measures

Name	Time	Method
Number of participants reporting treatment-emergent serious adverse events (TESAEs)	Up to 29 Weeks
Proportion of participants with mean Hb levels within target range	Week 16 to Week 24
Proportion of participants receiving red blood cell (RBC) transfusions	Up to 29 Weeks