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:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT04409132
Eligibility Criteria:
Inclusion Criteria:
* Adult hemodialysis patients ≥18 years of age.
* Signed informed consent to participate in the study.
* Stable on hemodialysis prescription for ≥3 months.
* Able to sustain hemodialysis 3x/week for 3 to 4 hours.
* Hemoglobin concentration \>9.5 g/dL.
* Serum TSAT ≥20%.
* Receiving hemodialysis via AV fistula or graft.
* Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
* Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.
* Serum TIBC ≥ 150 µg/dL.
Exclusion Criteria:
* Active bleeding disorder (GI, skin, nasal…)
* Receiving hemodialysis via catheter.
* Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
* Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
* Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04409132
Study Brief:
Protocol Section:
NCT04409132