Personalized Medicine for Membranous Nephropathy
Key facts
- Who runs it
- Centre Hospitalier Universitaire de Nice
- Where
- France19 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 68 people enrolled
- Started
- 14 Jan 2020
- Ended
- 5 Nov 2024
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Rituximab
- Record updated
- 25 July 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced)
- Secondary Membranous Nephropathy: Membranous Nephropathy related to cancer, infectious, systemic lupus erythematosis, drug
- 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
- Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- Pregnancy or breastfeeding
- Immunosuppressive treatment in the 3 last months
- Patients in a severely immunocompromised state
- Patients unable to give an informed consent
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
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* 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.
The 2 groups in the trial
- GEMRITUX protocolNo study treatment, for comparison
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 treatmentTreatment being tested
* 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.
Treatment: Rituximab
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 25 July 2025