Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-25 @ 3:17 AM
NCT ID:
NCT06901505
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.
* 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 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.
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06901505
Study Brief:
Protocol Section:
NCT06901505