Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Akebia Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
Currently prescribed or will be prescribed methoxy polyethylene glycol-epoetin beta.
Hb \<11.5 g/dL
You may not be if
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.
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
