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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT02093533
Eligibility Criteria:
Inclusion Criteria:
* Biopsy-proven primary MPGN
* Creatinine clearance \>20 ml/min per 1.73m2
* 24-hour proteinuria persistently exceeding 3,5g in adults or exceeding 40mg/h/m2 in children (or exceeding 2mg protein/mg creatinine in children spot urine samples)
* Persistently low C3 levels in at least two consecutive evaluations
* Persistently high sC5b9 levels (\>1000 ng/ml) in at least two previous consecutive evaluations
* Written informed consent (by parents or tutors if underage)
Exclusion Criteria:
* Age ≥75 years
* Secondary MPGN (evidence of infection, immunological disease including vasculitis, systemic diseases and proliferative disorders)
* Evidence at kidney biopsy evaluation of severe chronic histological changes that very unlikely could benefit of eculizumab therapy
* Concomitant steroid or immunosuppressive therapy for immuno-mediated disease
* Pregnancy or lactating
* Childbearing potential without effective contraception
* Any clinically relevant condition that might affect completion of the study participation and/or confound study results
* Inability to understand the potential risks and benefits of the study
* Legal incapacity
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT02093533
Study Brief:
Protocol Section:
NCT02093533