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

NCT06901505 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: AKB-6548-CI-0052VOCAL
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 18

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). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.

Conditions

Anemia of Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Hemodialysis; Erythropoiesis-Stimulating Agent; Open-label; Vadadustat

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin (Hb)

  Baseline and the mean of Week 20 to 24

Secondary Outcomes (3)

• 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 RBC transfusions

  Up to 29 Weeks

Study Arms (2)

Vadadustat

EXPERIMENTAL

Study drug will be administered three times a week.

Drug: Vadadustat

Erythropoiesis-Stimulating Agent (ESA)

ACTIVE COMPARATOR

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

Drug: Erythropoiesis-Stimulating Agent (ESA)

Interventions

Erythropoiesis-Stimulating Agent (ESA) DRUG

Administered by intra-venous (IV) infusion.

Erythropoiesis-Stimulating Agent (ESA)

Vadadustat DRUG

300mg, oral tablets

Also known as: Vafseo, AKB-6548

Vadadustat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Currently prescribed or will be prescribed methoxy polyethylene glycol-epoetin beta.
• Hb \<11.5 g/dL

You may not qualify if:

• 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.
• History of, or currently diagnosed with, any hematological disease, such as sickle cell disease, thalassemia, hemochromatosis, Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency, myelodysplastic syndromes, or any other blood disorder that could interfere with the study outcomes.
• Participants will receive a blood transfusion within 3 months prior to the initiation of the study.
• History of or currently diagnosed with chronic lung disease

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (18)

DaVita Research Site

Montgomery, Alabama, 36117-7306, United States

Location

DaVita Research Site

Hartford, Connecticut, 06112-1260, United States

Location

DaVita Research Site

Middlebury, Connecticut, 06705-3893, United States

Location

DaVita Research Site

Columbus, Georgia, 31904-3604, United States

Location

DaVita Research Site #1

Minneapolis, Minnesota, 55435-1807, United States

Location

DaVita Research Site

Minneapolis, Minnesota, 55435-1807, United States

Location

DaVita Research Site

Henderson, Nevada, 89052-5548, United States

Location

DaVita Research Site

Las Vegas, Nevada, 89128-0804, United States

Location

DaVita Research Site #1

El Paso, Texas, 79835-2200, United States

Location

DaVita Research Site

El Paso, Texas, 79835-2200, United States

Location

DaVita Research Site #1

Houston, Texas, 77054-3836, United States

Location

DaVita Research Site

Houston, Texas, 77054-3836, United States

Location

DaVita Research Site #1

San Antonio, Texas, 78258-4800, United States

Location

DaVita Research Site #2

San Antonio, Texas, 78258-4800, United States

Location

DaVita Research Site

San Antonio, Texas, 78258-4800, United States

Location

DaVita Research Site

The Woodlands, Texas, 77384-3024, United States

Location

DaVita Research Site #1

Norfolk, Virginia, 23502-3235, United States

Location

DaVita Research Site

Norfolk, Virginia, 23502-3235, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Hematinics; vadadustat

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: March 30, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)