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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02754167
Eligibility Criteria:
Inclusion Criteria:
* Patients with stage 5 chronic kidney disease having been on hemodialysis for at least 90 days
* Patients being on stable erythropoiesis-stimulating agent (ESA) dose
* Hemoglobin (Hb) 9 - 11 g/dL
* Ferritin ≥ 300 ng/mL.
* Transferrin saturation (TSAT) ≤ 30%
* Hepcidin 5 - 50 nmol/L
Exclusion Criteria:
* Anemia due to causes other than chronic kidney disease, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy
* Blood transfusion within 2 months before administration of study medication.
* Iron treatment from 1 week before study medication administration until 1 week after study medication administration.
* Previous enrollment in this study
* Current or previous (within 60 days before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study.
* Pregnancy or breast-feeding women of child bearing age.
* Known allergy to any component of the PRS-080#022-DP formulation
* Positive for hepatitis B surface antigen, anti-hepatitis C virus antibody, or human immunodeficiency virus
* Planned surgery during the study period
* Unwilling or unable to comply with the protocol, in the judgment of the investigator
* Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy or coronary artery bypass grafting \<3 months prior screening.
* Congestive heart failure: New York Heart Association Class III or IV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02754167
Study Brief:
Protocol Section:
NCT02754167