| Registry | NCT03804359, acronym PMMN |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 68 (Actual) |
| Sponsor | Centre Hospitalier Universitaire de Nice (Other) |
| Conditions | Idiopathic Membranous Nephropathy |
| Interventions | Rituximab (Drug) |
| Dates | start 2020-01-14, primary completion 2024-09-30, completion 2024-11-05, first posted 2019-01-15, last updated 2025-07-25 |
| Locations | 19 sites in France |
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All trials for Idiopathic Membranous Nephropathy All trials of Rituximab
Randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of Idiopathic Membranous Nephropathy with nephrotic syndrome and anti-PLA2R1 (phospholipase A2 receptor 1) antibodies:
* GEMRITUX protocol: 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (UPCR) remains > 3.5 g/g and albuminemia < 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval.
* Personalized treatment:
* restricted anti-CysR activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (KDIGO)
* restricted anti-CysR activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval;
* Anti-CTLD (C-type lectin domains ) 1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| GEMRITUX protocol | No intervention | 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (UPCR) remains > 3.5 g/g and albuminemia < 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval. | |
| Personalized treatment | Experimental | Drug: Rituximab | * restricted anti-CysR activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (KDIGO) * restricted anti-CysR activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval; * Anti-CTLD1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age 18 years or more * Anti-PLA2R1 activity detected by ELISA or Euroimmune Immunofluorescence Assay * Nephrotic syndrome defined by proteinuria > 3.5 g/24h (or UPCR > 3.5 g/g) and serum albumin < 30 g/L at diagnosis * eGFR (CKD-EPI) > 30 ml/min/1,73 m2 at diagnosis * Symptomatic treatment according to KDIGO guidelines: maximal tolerated dose of NIAT : Non Immunosuppressive Antiproteinuric Treatment (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins) * Medical insurance * Signed informed consent * Having understood and accepted the need for long-term medical follow-up * Woman of child-bearing age must be using an effective method of contraception Exclusion Criteria: * Secondary Membranous Nephropathy: Membranous Nephropathy related to cancer, infectious, systemic lupus erythematosis, drug * Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced) * Pregnancy or breastfeeding * Immunosuppressive treatment in the 3 last months * Cancer under treatment * Patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failure…) * Patients with active, severe infections or active hepatitis B * Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients * Patients in a severely immunocompromised state * Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease * Patients unable to give an informed consent
| Facility | City | Country | Status |
|---|---|---|---|
| CHU D'amiens Hôpital Sud | Amiens | France | |
| CHU Besançon | Besançon | France | |
| Hôpital universitaire La Cavale Blanche | Brest | France | |
| CHU de Caen | Caen | France | |
| CHU Gabriel Montpied | Clermont-Ferrand | France | |
| CHU Henri Mondor | Créteil | France | |
| CHRU de LILLE | Lille | France | |
| CHU de LYON NORD | Lyon | France | |
| AP-HM | Marseille | France | |
| CHRU de Montpellier | Montpellier | France | |
| CHU de NANTES | Nantes | France | |
| Dr Barbara SEITZ-POLSKI | Nice | France | |
| CHU Carémeau | Nîmes | France | |
| Hôpital Necker | Paris | France | |
| Le Kremlin Bicêtre | Paris | France | |
| Hôpital de la maison blanche | Reims | France | |
| CHU de Strasbourg | Strasbourg | France | |
| CHU de Toulouse | Toulouse | France | |
| CHU de Tours | Tours | France |