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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT02260193
Eligibility Criteria:
Key Inclusion Criteria:
* 18 to 79 years inclusive
* Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months
* Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous iron
Key Exclusion Criteria:
* Body mass index \>44.0 kilograms per meter squared (kg/m\^2)
* Transfusion within 8 weeks prior to Screening
* Alanine transaminase or total bilirubin \>1.25x ULN
* Uncontrolled hypertension
* Class III or IV congestive heart failure
* Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack within 6 months prior to Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02260193
Study Brief:
Protocol Section:
NCT02260193