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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT03804359
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or more
* Anti-PLA2R1 activity detected by ELISA or Euroimmune Immunofluorescence Assay
* Nephrotic syndrome defined by proteinuria \> 3.5 g/24h (or UPCR \> 3.5 g/g) and serum albumin \< 30 g/L at diagnosis
* eGFR (CKD-EPI) \> 30 ml/min/1,73 m2 at diagnosis
* Symptomatic treatment according to KDIGO guidelines: maximal tolerated dose of NIAT : Non Immunosuppressive Antiproteinuric Treatment (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins)
* Medical insurance
* Signed informed consent
* Having understood and accepted the need for long-term medical follow-up
* Woman of child-bearing age must be using an effective method of contraception
Exclusion Criteria:
* Secondary Membranous Nephropathy: Membranous Nephropathy related to cancer, infectious, systemic lupus erythematosis, drug
* Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced)
* Pregnancy or breastfeeding
* Immunosuppressive treatment in the 3 last months
* Cancer under treatment
* Patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failure…)
* Patients with active, severe infections or active hepatitis B
* Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
* Patients in a severely immunocompromised state
* Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
* Patients unable to give an informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03804359
Study Brief:
Protocol Section:
NCT03804359