Informations générales (source: ClinicalTrials.gov)
Personalized Medicine for Membranous Nephropathy (PMMN)
Interventional
Phase 2
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
janvier 2020
septembre 2023
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | Antoine DURRBACH | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Vincent AUDARD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Bertrand KNEBELMANN | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Besançon - 25000 - Besançon - France | Céline COURNIVAUD | Contact (sur clinicalTrials) | |||
| CHU Carémeau - 30029 - Nîmes - France | Olivier MORANNE | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14033 - Caen - France | Antoine LANOT | Contact (sur clinicalTrials) | |||
| CHU de Strasbourg - 67091 - Strasbourg - France | Thierry KRUMMEL | Contact (sur clinicalTrials) | |||
| CHU de Tours - 37044 - Tours - France | Jean-Michel HALIMI | Contact (sur clinicalTrials) | |||
| Hôpital de la maison blanche - 51092 - Reims - France | Philippe RIEU | Contact (sur clinicalTrials) | |||
| Hôpital universitaire La Cavale Blanche - 29069 - Brest - France | Emilie CORNEC-LE GALL | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - 13005 - Marseille - France | Noémie JOURDE-CHICHE | Contact (sur clinicalTrials) | |||
| CHRU de LILLE - 59037 - Lille - France | Céline LEBAS | Contact (sur clinicalTrials) | |||
| CHRU de Montpellier - 34295 - Montpellier - France | Moglie LE QUINTREC | Contact (sur clinicalTrials) | |||
| CHU D'amiens Hôpital Sud - 80800 - Amiens - France | Gabriel CHOUKROUN | Contact (sur clinicalTrials) | |||
| CHU de LYON NORD - 69437 - Lyon - France | Fitsum GUEBRE-EGZIABHER | Contact (sur clinicalTrials) | |||
| CHU de NANTES - 44093 - Nantes - France | Fadi FAKHOURI | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - 31059 - Toulouse - France | Dominique CHAUVEAU | Contact (sur clinicalTrials) | |||
| CHU Gabriel Montpied - 63000 - Clermont-Ferrand - France | Anne-Elisabeth HENG | Contact (sur clinicalTrials) | |||
| Dr Barbara SEITZ-POLSKI - 06000 - Nice - France | Barbara SEITZ-POLSKI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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