AI-guided personalized rituximab for membranous nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial uses an artificial intelligence model to personalize rituximab dosing for adults with PLA2R1-positive membranous nephropathy and nephrotic syndrome. Participants receive rituximab injections guided by the AI algorithm, with clinical and laboratory follow-up to monitor antibody levels, proteinuria, and kidney function. The trial tracks treatment response and safety over predefined time points to determine whether personalized dosing reduces nonresponse linked to urinary drug loss. The study is conducted at multiple French university hospitals.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de BESANCON
  Besançon, France Recruiting
• CHU de BORDEAUX - Hôpital Pellegrin
  Bordeaux, France Recruiting
• CHU de CAEN
  Caen, France Recruiting
• AP-HP - Hôpital H. Mondor
  Créteil, France Recruiting
• HCL - Hôpital E. Herriot
  Lyon, France Recruiting
• AP-HM - Hôpital de la Conception
  Marseille, France Recruiting

Study contacts

• Study coordinator: Barbara SEITZ-POLSKI, MD, PhD
• Email: seitz-polski.b@chu-nice.fr
• Phone: +33492038828

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.