Personalized Medicine for Membranous Nephropathy

Last updated: July 24, 2025
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Completed

Phase

2

Condition

Nephrotic Syndrome

Idiopathic Membranous Nephropathy

Glomerulonephritis

Treatment

Rituximab

Clinical Study ID

NCT03804359
17-APN-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 serumalbumin < 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 enzymeinhibitor 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

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 patientwill be replaced)

  • Pregnancy or breastfeeding

  • Immunosuppressive treatment in the 3 last months

  • Cancer under treatment

  • Patient with complicated nephrotic syndrome that would require earlyimmunosuppressive 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 theother excipients

  • Patients in a severely immunocompromised state

  • Severe heart failure (New York Heart Association Class IV) or severe, uncontrolledcardiac disease

  • Patients unable to give an informed consent

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: Rituximab
Phase: 2
Study Start date:
January 14, 2020
Estimated Completion Date:
November 05, 2024

Connect with a study center

  • CHU D'amiens Hôpital Sud

    Amiens, 80800
    France

    Site Not Available

  • CHU Besançon

    Besançon, 25000
    France

    Site Not Available

  • Hôpital universitaire La Cavale Blanche

    Brest, 29069
    France

    Site Not Available

  • CHU de Caen

    Caen, 14033
    France

    Site Not Available

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • CHU Henri Mondor

    Créteil, 94010
    France

    Site Not Available

  • CHRU de LILLE

    Lille, 59037
    France

    Site Not Available

  • CHU de LYON NORD

    Lyon, 69437
    France

    Site Not Available

  • AP-HM

    Marseille, 13005
    France

    Site Not Available

  • CHRU de Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • CHU de NANTES

    Nantes, 44093
    France

    Site Not Available

  • Dr Barbara SEITZ-POLSKI

    Nice, 06000
    France

    Site Not Available

  • CHU Carémeau

    Nîmes, 30029
    France

    Site Not Available

  • Hôpital Necker

    Paris, 75015
    France

    Site Not Available

  • Le Kremlin Bicêtre

    Paris, 94275
    France

    Site Not Available

  • Hôpital de la maison blanche

    Reims, 51092
    France

    Site Not Available

  • CHU de Strasbourg

    Strasbourg, 67091
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • CHU de Tours

    Tours, 37044
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.