CompletedPhase 2

Personalized Medicine for Membranous Nephropathy

France68 participantsStarted 2020-01-14

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Clinical remission will be defined as a composite criterion combining (KDIGO definitions)

Timeframe: 6 months

Trial details

NCT IDNCT03804359

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30