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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-24

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia of Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vadadustat

Study drug will be administered three times a week.

Group Type EXPERIMENTAL

Vadadustat

Intervention Type DRUG

300mg, oral tablets

Erythropoiesis-Stimulating Agent (ESA)

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

Group Type ACTIVE_COMPARATOR

Erythropoiesis-Stimulating Agent (ESA)

Intervention Type DRUG

Administered by intra-venous (IV) infusion.

Interventions

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Erythropoiesis-Stimulating Agent (ESA)

Administered by intra-venous (IV) infusion.

Intervention Type DRUG

Vadadustat

300mg, oral tablets

Intervention Type DRUG

Other Intervention Names

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Vafseo AKB-6548

Eligibility Criteria

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

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.
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No