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NCT Number: NCT06901505

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DaVita Research Site, Montgomery, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • For selected sites, individuals who opt to participate in the RBC sub-study must meet the following inclusion criteria:
  • 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.
  • For selected sites, individuals who opt to participate in the RBC sub-study must also not meet the following exclusion criteria:
  • 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

Treatment and study plan

Erythropoiesis-stimulating agent (ESA)

Drug

Administered by intra-venous (IV) infusion.

Vadadustat

Drug

300mg, oral tablets

Other names: Vafseo, AKB-6548

Primary outcomes

  1. Change in hemoglobin (Hb)

    Time frame: Baseline and the mean of Week 20 to 24

Secondary outcomes

  1. Number of participants reporting treatment-emergent serious adverse events (TESAEs)

    Time frame: Up to 29 Weeks

  2. Proportion of participants with mean Hb levels within target range

    Time frame: Week 16 to Week 24

  3. Proportion of participants receiving RBC transfusions

    Time frame: Up to 29 Weeks

Sponsors and collaborators

Lead sponsor

Akebia Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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