A Phase 2 interventional study of Rituximab in Idiopathic Membranous Nephropathy, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 19 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 2, Interventional, and Treatment
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:
Personalized treatment:
116 studies on the registry are indexed under Glomerulonephritis, Membranous; 39 are open to participants now.
This study's enrollment of 68 is above the median of 34 across 82 interventional studies indexed under Glomerulonephritis, Membranous.
Browse Glomerulonephritis, Membranous studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
* 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-CTLD1/7 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.
Drug: Rituximab
In the "personalized arm", the patient will be treated in function of the CysR activity result during the inclusion visit.
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
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Glomerulonephritis, Membranous→
Centre Hospitalier Universitaire de Nice