Personalized Medicine for Membranous Nephropathy

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.

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Key information

Conditions

Idiopathic Membranous Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranous Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Nephrosis Nephrotic Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU D'amiens Hôpital Sud, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 severe, uncontrolled cardiac disease
Patients unable to give an informed consent

Treatment and study plan

Rituximab

Drug

In the "personalized arm", the patient will be treated in function of the CysR activity result during the inclusion visit.

Primary outcomes

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

Time frame: 6 months
- 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%

Secondary outcomes

Immunological remission

Time frame: 6 months

full PLA2R1 depletion measured by ELISA (titer<14RU (relative units) /ml)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PMMN

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2024
First posted: Jan 15, 2019
Registry last updated: Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed