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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT03079518
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent.
* Age \> 18 yrs
* Symptomatic HFREF (LV ejection fraction \< 45%) with optimal medical therapy (OMT) for at least 2 months
* Iron deficiency as indicated by by ferritin \<100 ng/mL or ferritin 100-299 ng/ml when transferrin saturation (TSAT) \<20% and Hb value \< 13mg/dl (women) and \<14 mg/dl (men)
* Group A: Stable CKD for at least 2 months, defined by estimated glomerular filtration rate (eGFR) (CKD-EPI formula) as 15-60 ml/min/1,73 m3 (CKD III, IV, V-non D)
* Group B: patients with stable eGFR \> 60 ml/min/1,73 m3
Exclusion Criteria:
* Known hypersensitivity to ferric carboxymaltose or any constituents of the formulation,
* Plasma Phosphate \< 2.5 mg/dL at screening,
* Renal replacement therapy/transplantation,
* Pregnancy or lactation
* iron substitution therapy or erythropoetin (epo) therapy within 6 weeks before
* participation in another clinical trial with an experimental drug
* expectation of missing compliance
* alcohol or drug abuse
* The subject is mentally or legally incapacitated
* patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03079518
Study Brief:
Protocol Section:
NCT03079518