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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 14, 2020
Primary Completion Date
September 30, 2024
Completion Date
November 5, 2024
Last Updated
July 25, 2025
68
ACTUAL participants
Rituximab
DRUG
Lead Sponsor
Centre Hospitalier Universitaire de Nice
NCT05782933
NCT03864250
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01180036