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

Korábbi kezelés

• 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.

Más betegség

• Known cirrhosis or active, acute liver disease.
• History of or currently diagnosed with chronic lung disease

Laborértékek

• 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.

Egyéb

• 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:

• 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