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Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX)

RecruitingPhase 3Ages 18 Years - anyAllCentre Hospitalier Universitaire de Nice
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In plain words

What the trial is, and whether it could suit you

Membranous nephropathy is an autoimmune disease affecting the kidney, and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. The course of this disease is highly variable from one individual to another, ranging from spontaneous remission to progressive chronic kidney disease. The identification of autoantibodies - e.g., the phospholipase A2 receptor type 1 (PLA2R1) - has promoted the use of immunosuppressive drugs such as rituximab which is now a safe and effective first-line treatment for the management of membranous nephropathy. However, up to 40% of patients do not respond to a first course of rituximab treatment. In nephrotic patients, due to urinary drug loss, rituximab blood level is lower than in other autoimmune diseases treated with rituximab without proteinuria. This high urinary drug loss decreases the drug exposure, potentially explaining why ritux

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📋 Eligibility rules (as published)
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
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What it tests

  • RiTUXimab Injection
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Where

14 sites
CHU de BESANCON
Besançon, France
CHU de BORDEAUX - Hôpital Pellegrin
Bordeaux, France
CHU de CAEN
Caen, France
AP-HP - Hôpital H. Mondor
Créteil, France
HCL - Hôpital E. Herriot
Lyon, France
AP-HM - Hôpital de la Conception
Marseille, France
CHU de NICE
Nice, France
CHU de Nîmes - Hôpital CAREMEAU
Nîmes, France

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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