protocolSection identificationModule nctId: NCT06341205, orgStudyIdInfo id: 22-APN-01, briefTitle: Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX), acronym: iRITUX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2031-08-31, completionDateStruct date: 2031-09-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: 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 rituximab regimen with low dose infusions (375 mg/m2) did not demonstrate efficacy after month-6 compared to a non-immunosuppressive antiproteinuric treatment in a previous study. In contrast, a regimen of two 1-g infusions two weeks apart was associated with a significantly greater remission rate after 6 months.Recently, the investigators have shown that after two 1-g rituximab infusions, the rituximab blood level 3 months after the first rituximab infusion, was correlated with the likelihood of remission after 6 and 12 months of the rituximab treatment. Patients with positive rituximab blood level 3 months after treatment had a higher chance of remission at month-6 and at month-12 than patients with an undetectable rituximab level at month-3.Nowadays, machine learning algorithms are increasingly used in medicine, especially in pharmacology, to predict the exposure to a drug, the initial dose to administer or the interval between two infusions.The objective of this study is to use a machine learning algorithm predicting the risk of having an undetectable residual level of rituximab 3 months after treatment, in order to propose a personalized treatment management with early additional doses of rituximab for the patients at risk., conditionsModule conditions: Membranous Nephropathy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: RiTUXimab Injection, outcomesModule primaryOutcomes measure: Clinical remission (complete or partial) after 6 months of rituximab initiation, secondaryOutcomes measure: Complete clinical remission after 12 months of rituximab initiation, secondaryOutcomes measure: Partial clinical remission after 12 months of rituximab initiation, secondaryOutcomes measure: Immunological remission: anti-PLA2R1 depletion, secondaryOutcomes measure: Change in urine protein/creatinine ratio (UPCR), secondaryOutcomes measure: Change in serum creatinine, secondaryOutcomes measure: Change in renal function, secondaryOutcomes measure: Change in the immunological status of the disease, secondaryOutcomes measure: Appearance of anti-drug antibodies after rituximab treatment, secondaryOutcomes measure: Rituximab underdosed patients, secondaryOutcomes measure: Serious adverse events, secondaryOutcomes measure: Adaptation of symptomatic treatment, secondaryOutcomes measure: Model improvement through machine learning, secondaryOutcomes measure: Effect of rituximab on immune profiles, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False