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

Launched by AKEBIA THERAPEUTICS · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called vadadustat, which is given three times a week, to see how well it works in treating anemia in patients with end-stage kidney disease who are receiving in-center hemodialysis. Anemia is a condition where you don't have enough red blood cells, which can make you feel tired and weak. The study will compare vadadustat to the standard treatment that patients usually receive, known as erythropoiesis-stimulating agents (ESAs). The trial will last about 33 weeks and is designed for adults aged 18 and older who are currently on hemodialysis and have specific blood test results that show they could benefit from this study.

To join the trial, participants need to be receiving hemodialysis at least three times a week and have certain levels of hemoglobin and iron in their blood. They should also be able to understand the study and give their consent. However, some people won't be able to participate, such as those with certain liver conditions or those who are pregnant. Participants in the trial can expect regular check-ins and monitoring to see how they respond to the treatment and to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• 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.
• 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.