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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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). 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.

Official Title

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

Quick Facts

Study Start:2025-07-24
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06901505

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult participants ≥18 years of age.
  2. * Receiving outpatient in-center hemodialysis for ESKD at least three times a week.
  3. * Currently prescribed or meets criteria for ESA based on approved facility policy.
  4. * Hb \> 8 grams per deciliter (g/dl).
  5. * Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20%.
  6. * Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
  7. * For selected sites, individuals who opt to participate in the RBC sub-study must meet the following
  1. * Contraindication to receive vadadustat per United States prescribing information (USPI) as determined by the treating health care provider.
  2. * Concomitant use of any hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI).
  3. * Known cirrhosis or active, acute liver disease.
  4. * 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.
  5. * Pregnant at the time of consent (per participant self-report).
  6. * Any other reason, which in the opinion of the Investigator, would make the participants unsuitable for participation in the study.
  7. * For selected sites, individuals who opt to participate in the RBC sub-study must also not meet the following

Contacts and Locations

Study Contact

Akebia Therapeutics
CONTACT
16178446128
trials@akebia.com

Study Locations (Sites)

DaVita Research Site
Montgomery, Alabama, 36117-7306
United States
DaVita Research Site
Hartford, Connecticut, 06112-1260
United States
DaVita Research Site
Middlebury, Connecticut, 06705-3893
United States
DaVita Research Site
Columbus, Georgia, 31904-3604
United States
DaVita Research Site #1
Minneapolis, Minnesota, 55435-1807
United States
DaVita Research Site
Minneapolis, Minnesota, 55435-1807
United States
DaVita Research Site
Henderson, Nevada, 89052-5548
United States
DaVita Research Site
Las Vegas, Nevada, 89128-0804
United States
DaVita Research Site #1
El Paso, Texas, 79835-2200
United States
DaVita Research Site
El Paso, Texas, 79835-2200
United States
DaVita Research Site #1
Houston, Texas, 77054-3836
United States
DaVita Research Site
Houston, Texas, 77054-3836
United States
DaVita Research Site #1
San Antonio, Texas, 78258-4800
United States
DaVita Research Site #2
San Antonio, Texas, 78258-4800
United States
DaVita Research Site
San Antonio, Texas, 78258-4800
United States
DaVita Research Site
The Woodlands, Texas, 77384-3024
United States
DaVita Research Site #1
Norfolk, Virginia, 23502-3235
United States
DaVita Research Site
Norfolk, Virginia, 23502-3235
United States

Collaborators and Investigators

Sponsor: Akebia Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-24
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-07-24
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Anemia of Chronic Kidney Disease