NCT06901505CompletedPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 353 (actual)
- First submitted
- 27 Mar 2025
- Start date
- 24 Jul 2025
- Primary completion date
- 12 Aug 2026
- Lead sponsor
- Akebia Therapeutics
- Diseases
- Chronic kidney disease
- NCT number
- NCT06901505
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 353
- From 24 Jul 2025 to the primary completion date, 12 Aug 2026
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of any hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI).
- Participants will receive a blood transfusion within 3 months prior to the initiation of the study.
Other illness
- Known cirrhosis or active, acute liver disease.
- History of or currently diagnosed with chronic lung disease
Lab values
- 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.
Other
- Contraindication to receive vadadustat per United States prescribing information (USPI) as determined by the treating health care provider.
- 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:
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.