RecruitingPHASE3NCT06341205

Study of Artificial Intelligence-based Personalized Rituximab Treatment Protocol in Membranous Nephropathy

Sponsor: Centre Hospitalier Universitaire de Nice

Trial Details

ConditionMembranous Nephropathy
InterventionRiTUXimab Injection
PhasePHASE3
StatusRecruiting
Participants120
Est. Completion31 Aug 2031
Last Updated22 June 2026

Primary Outcome

Clinical remission (complete or partial) after 6 months of rituximab initiation

Eligibility Criteria

Inclusion 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

Trial Sites

Countries

France
View Registry Entry

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