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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04464850
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Hemodialysis for at least 3 months
* Hemoglobin levels between 8 and 11.5 g/dl inclusive
* Transferrin saturation (TSAT) \<50% and ferritin \<800 mg/dl
* Stable dose of epoetin of any types and iron therapy for at least 1 month
Exclusion Criteria:
* History of iron allergy
* Pregnant or lactating women
* Patients with known hematologic disorders other than anemia of renal disease and iron deficiency anemia
* Patients with hemoglobinopathy e.g., thalassemia
* Patients with iron overload or hemochromatosis
* Patients with gastrointestinal hemorrhage during 6 months before enrolment in to the study
* Patients with current severe infection
* Patients with any malignancies
* Patients with severe psychiatric illness
* Patients with any other medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
* Patients who currently receive medications that can altered gastrointestinal absorption of oral iron e.g., aluminum carbonate, aluminum hydroxide, chloramphenicol, dimercaprol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04464850
Study Brief:
Protocol Section:
NCT04464850