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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
In the "personalized arm", the patient will be treated in function of the CysR activity result during the inclusion visit.
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
...and 9 more locations
Clinical remission will be defined as a composite criterion combining (KDIGO definitions)
* Complete clinical remission: urinary protein/creatinine ratio (UPCR)\<0.3 g/g in spot morning urine samples and serum albumin \> 35 g/L and eGFR (epidermal growth factor receptor) \> 60 ml/min/1.73 m2 * Partial clinical remission: UPCR \< 3.5 g/g with a decrease greater than 50% from baseline and serum albumin \> 30 g/L and increase of serum creatinine lower than 20%
Time frame: 6 months
Immunological remission
full PLA2R1 depletion measured by ELISA (titer\<14RU (relative units) /ml)
Time frame: 6 months
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