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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT06341205
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Ongoing episode of membranous nephropathy diagnosed by the presence of anti-PLA2R1 antibodies detected by ELISA (≥ 14 RU/ml, EUROIMMUN): the result must be validated by the Coordination team before randomization.
* Nephrotic syndrome defined by proteinuria \> 3.5 g/24h (or UPCR \> 3.5 g/g) and serum albumin \< 30 g/L at diagnosis
* Estimated Glomerular Filtration Rate (CKD-EPI formula) \> 30 mL/min/1,73 m2
* Indication for rituximab treatment according to the KDIGO and French guidelines
* Non-immunosuppressive antiproteinuric treatment at stable dose for 2 weeks according to French guidelines, including a renin angiotensin aldosterone system inhibitor, a diuretic and a low-salt diet at maximal tolerated dose (i.e., absence of orthostatic hypotension and no increase in creatinine \> 30%)
Exclusion Criteria:
* Secondary Membranous nephropathy related to cancer, infection, systemic lupus, drug
* Diagnosis of PLA2R1-associated Membranous nephropathy not confirmed by the Coordination team (validation mandatory for randomization)
* Pregnancy or breastfeeding
* Immunosuppressive treatment (including rituximab) in the 6 months preceding inclusion
* Presence of anti-rituximab antibodies detected by Central Lab
* Cancer under treatment
* Patients with active, severe infections
* Hypersensitivity to the active substance or excipients
* Patients severely immunocompromised
* Severe heart failure or severe, uncontrolled cardiac disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06341205
Study Brief:
Protocol Section:
NCT06341205