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Idiopathic Membranous NephropathyPhase 2PMMNNCT03804359

Personalized Medicine for Membranous Nephropathy

A Phase 2 study testing Rituximab in people with Idiopathic Membranous Nephropathy, run by Centre Hospitalier Universitaire de Nice at 19 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Membranous Nephropathy
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
19 sitesFrance
Study dates
14 Jan 2020to 5 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 join

  • 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…)
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  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • CHU D'amiens Hôpital Sud

    Amiens, 80800

  • CHU Besançon

    Besançon, 25000

  • Hôpital universitaire La Cavale Blanche

    Brest, 29069

  • CHU de Caen

    Caen, 14033

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63000

  • CHU Henri Mondor

    Créteil, 94010

  • CHRU de LILLE

    Lille, 59037

  • CHU de LYON NORD

    Lyon, 69437

  • AP-HM

    Marseille, 13005

  • CHRU de Montpellier

    Montpellier, 34295

  • CHU de NANTES

    Nantes, 44093

  • Dr Barbara SEITZ-POLSKI

    Nice, 06000

  • CHU Carémeau

    Nîmes, 30029

  • Hôpital Necker

    Paris, 75015

  • Le Kremlin Bicêtre

    Paris, 94275

  • Hôpital de la maison blanche

    Reims, 51092

  • CHU de Strasbourg

    Strasbourg, 67091

  • CHU de Toulouse

    Toulouse, 31059

  • CHU de Tours

    Tours, 37044

Other trials in France

About this study

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.
Being tested
Rituximab
Keywords
Nephrotic Syndrome, PLA2R1-antibodies, Epitope spreading, Rituximab
Medical subject headings
Glomerulonephritis, Membranous, Nephrotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

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

Study groups in NCT03804359
Study groupRoleWhat they receive
GEMRITUX protocolNo intervention6 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 treatmentExperimental* 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.
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: 6 months

Secondary outcomes (1)

  1. Immunological remission

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start14 Jan 2020
  3. Primary completion30 Sep 2024
  4. Study completion5 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03804359
Sponsor's protocol ID
17-APN-01
Acronym
PMMN
Status last verified
Jul 2025
First submitted
11 Jan 2019
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Simon N, Courouce AM, Lemarrec N, Trepo C, Ducamp S. A twelve year natural history of hepatitis C virus infection in hemodialyzed patients. Kidney Int. 1994 Aug;46(2):504-11. doi: 10.1038/ki.1994.301.

    PubMed 7967364

  • Simon P, Ramee MP, Boulahrouz R, Stanescu C, Charasse C, Ang KS, Leonetti F, Cam G, Laruelle E, Autuly V, Rioux N. Epidemiologic data of primary glomerular diseases in western France. Kidney Int. 2004 Sep;66(3):905-8. doi: 10.1111/j.1523-1755.2004.00834.x.

    PubMed 15327379

  • Ponticelli C. Membranous nephropathy. J Nephrol. 2007 May-Jun;20(3):268-87.

    PubMed 17557260

  • Glassock RJ. The pathogenesis of idiopathic membranous nephropathy: a 50-year odyssey. Am J Kidney Dis. 2010 Jul;56(1):157-67. doi: 10.1053/j.ajkd.2010.01.008. Epub 2010 Apr 8.

    PubMed 20378220

  • Lassalle M, Ayav C, Frimat L, Jacquelinet C, Couchoud C; Au Nom du Registre REIN. The essential of 2012 results from the French Renal Epidemiology and Information Network (REIN) ESRD registry. Nephrol Ther. 2015 Apr;11(2):78-87. doi: 10.1016/j.nephro.2014.08.002. Epub 2014 Nov 1.

    PubMed 25457107

  • Brglez V, Boyer-Suavet S, Zorzi K, Fernandez C, Fontas E, Esnault V, Seitz-Polski B. Personalized Medicine for PLA2R1-Related Membranous Nephropathy: A Multicenter Randomized Control Trial. Front Med (Lausanne). 2020 Aug 13;7:412. doi: 10.3389/fmed.2020.00412. eCollection 2020.

    PubMed 32903623

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab in people with Idiopathic Membranous Nephropathy, run by Centre Hospitalier Universitaire de Nice at 19 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical remission will be defined as a composite criterion combining (KDIGO definitions) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03804359, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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