Status:
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
Lead Sponsor:
Akebia Therapeutics
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-stimu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06901505
Start Date
July 24 2025
End Date
June 1 2026
Last Update
September 25 2025
Active Locations (18)
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1
DaVita Research Site
Montgomery, Alabama, United States, 36117-7306
2
DaVita Research Site
Hartford, Connecticut, United States, 06112-1260
3
DaVita Research Site
Middlebury, Connecticut, United States, 06705-3893
4
DaVita Research Site
Columbus, Georgia, United States, 31904-3604