Personalized Medicine for Membranous Nephropathy — PMMN  

Idiopathic Membranous Nephropathy Clinical Trial

Official title: Personalized Medicine for Membranous Nephropathy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

• NCT number: NCT03804359
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Barbara SEITZ-POLSKI, MD
• Phone: 04 92 03 55 02
• Email: seitz-polski.b@chu-nice.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: January 14, 2020
• Completion date: September 2023