RECRUITING

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

Description

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.

Conditions

Anemia of Chronic Kidney Disease
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Related Conditions:

Anemia of Chronic Kidney Disease

Study Overview

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Study Details

Study overview

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.

A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis

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

Condition
Anemia of Chronic Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Montgomery

DaVita Research Site, Montgomery, Alabama, United States, 36117-7306

Hartford

DaVita Research Site, Hartford, Connecticut, United States, 06112-1260

Middlebury

DaVita Research Site, Middlebury, Connecticut, United States, 06705-3893

Columbus

DaVita Research Site, Columbus, Georgia, United States, 31904-3604

Minneapolis

DaVita Research Site #1, Minneapolis, Minnesota, United States, 55435-1807

Minneapolis

DaVita Research Site, Minneapolis, Minnesota, United States, 55435-1807

Henderson

DaVita Research Site, Henderson, Nevada, United States, 89052-5548

Las Vegas

DaVita Research Site, Las Vegas, Nevada, United States, 89128-0804

El Paso

DaVita Research Site #1, El Paso, Texas, United States, 79835-2200

El Paso

DaVita Research Site, El Paso, Texas, United States, 79835-2200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Akebia Therapeutics,

Study Record Dates

2026-06