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Membranous NephropathyIHMNNCT04326218

Immunopathological Analysis in a French National Cohort of Membranous Nephropathy

A study testing Blood sample in people with Membranous Nephropathy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

National cohort of all cases of membranous nephropathy (MN) during a 1 year period in France, based on a pathological and/or serological diagnostic, collecting the data on: incidence of MN prevalence of anti-PLA2R1 and anti-THSD7A clinical outcome one year after diagnosis or after relapse (complete remission, partial… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Membranous Nephropathy
What is being tested?
Blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteFrance
Study dates
4 Jul 2020to 3 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Biopsy on a native kidney consistent with MN and/or positivity for serum anti-PLA2R1 and/or anti-THSD7A antibodies
  • Signed informed consent

Who cannot join

  • Diagnosis error based on the kidney biopsy staining or on serology analyses for the positivity for anti-PLA2R1 and/or anti-THSD7A
  • Patients unable to give an informed consent
  • Patients withdrawing an informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Barbara SEITZ-POLSKI, MD contact

+33 4 92 03 55 02

seitz-polski.b@chu-nice.fr

France1 site, 1 recruiting

  • CHU de Nice, Hôpital de l'Archet

    Nice, Alpes Maritime, 06200

    Barbara Seitz-Polski, +33492035502, seitz-polski.b@chu-nice.fr

    Barbara SEITZ-POLSKI, PhD

    Recruiting

Other trials in France

About this study

Official title: Immunopathological Analysis in a French National Cohort of Membranous Nephropathy (IHMN)

National cohort of all cases of membranous nephropathy (MN) during a 1 year period in France, based on a pathological and/or serological diagnostic, collecting the data on:

  • incidence of MN
  • prevalence of anti-PLA2R1 and anti-THSD7A
  • clinical outcome one year after diagnosis or after relapse (complete remission, partial remission or persistent nephrotic syndrome)
  • environmental risk factors for the onset of MN
  • HLA markers
  • patient care status in France
Read the detailed description

Membranous nephropathy is a rare auto-immune disease, yet a major cause of nephrotic syndrome in adults. It is characterised by the deposition of antigen-antibody complexes on the glomerular basement membrane, leading to a decreased filtration rate and eventually kidney failure. About one third of cases have a favourable outcome without any treatment, another third requires a long term symptomatic treatment to manage their symptoms, and the last third of patients advances to end stage renal failure, requiring dialysis and kidney graft. MN can be associated with cancer, infections, other auto-immune diseases and with certain drugs (secondary MN), but most often it is idiopathic. In the latter form two antigens have been identified, PLA2R1 and THSD7A, with corresponding auto-antibodies in 70% and 2% of MN patients, respectively. GWAS studies identified several alleles associated with a higher risk of developing MN, however, since these are common variants they cannot explain the onset of MN in the vast majority of cases. Since MN is a rare disease, the number of new cases per each center is low, and nation-wide studies are needed to correctly evaluate its incidence and risk factors for the onset of MN, as well as validate previously published findings in monocentric studies on the prognostic value of PLA2R1 epitope spreading (immunisation against multiple domains of PLA2R1).

This study aims to establish a French national cohort of all cases of MN in a one year period in France. The inclusion will last one year with one additional year of follow-up, for a total of 2 years. In the first year, nephrologists of each associate centers in France will propose the study to each of their patients diagnosed with MN. In addition, clinical information will be collected, as well as a survey on patients' lifestyle habits. Serum samples will be sent for centralised analyses in Nice.

This study will help to clarify the results from single center studies, such as the prognostic value of epitope spreading. The information acquired on environmental risk factors will help us understand the pathophysiological mechanisms leading to the onset of MN et, by association, to other auto-immune diseases. With this knowledge, measures could be put in place to protect the population at risk.

Being tested
Blood sample
Medical subject headings
Glomerulonephritis, Membranous

What participants receive

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

  • Blood sampleOther

    Serum samples will be sent for centralised analyses in Nice.

    On these samples, different analysis will be performed :

    • anti-PLA2R1 and anti-THSD7A antibodies
    • anti-PLA2R1 and anti-THSD7A epitopes
    • HLA typing
Study groups in NCT04326218
Study groupRoleWhat they receive
CohortOtherAll patients included will have to be taken blood samples
Receives: Other: Blood sample

What is being measured

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

  1. To determine the incidence of Membranous Nephropathy (MN) and its evolution

    as either complete remission (UPCR < 0.3 g/g, serum albumin > 35 g/L, eGFR > 60 ml/min/1.73 m²) or partial remission (UPCR < 3.5 g/g and reduction of at least 50% from baseline, < 20% increase of serum creatinin from baseline) or persistent nephrotic syndrome (UPCR > 3.5 g/g, serum albumin < 30 g/L)

    Measured: one year after inclusion

Secondary outcomes (6)

  1. Determination of incidence of primary and secondary forms of MN

    Measured: 24 months

  2. Identification of environmental factors associated with the onset of MN

    Thanks to a specific questionnaire data on medical history, lifestyle, demography and profession will be collected

    • Medical history: prior diagnosis of any autoimmune disease, cancer, infection or other, infection in the month before the diagnosis of MN, thrombosis, drugs taken at the moment of diagnosis, allergies and type of symptomes
    • Emotional state: emotional state at diagnosis, stressful or destabilizing event in the year preceding diagnosis of MN

    Measured: 24 months

  3. Description of the standard of care for patients with MN in France

    Treatment names and their duration (in weeks) will be collected

    Measured: 24 months

  4. the prognostic value of epitope spreading in patients with PLA2R1-associated MN

    Epitope spreading status is determined by measuring the positivity to anti-CysR, anti-CTLD1 and CTLD7 antibodies in the serum, by the means of ELISA and expressed as RU/mL. The patients with antibodies targetting CysR only are considered as non-spreaders, while the patients additionnaly targetting either CTLD1 and/or CTLD7 are considered as spreaders. Epitope spreading status (non-spreader or spreader) will be correlated to clinical outcome (complete remission, partial remission or persistent nephrotic syndrome, as defined under primary outcome measures) one year after inclusion.

    Measured: 24 months

  5. Characterization of HLA typing of MN patients

    Isolation of DNA and genotyping will be performed with the use of standard procedures of Next Generation Sequencing

    Measured: 12 months

  6. Prognostic value of tissue staining for glomerular deposit of PLA2R1, THSD7A, as welle as of different IgG subclasses

    Positivity for PLA2R1, THSD7A and NELL-1 antigens will be determined using immunostaining with antibodies against PLA2R1, THSD7A and NELL-1, and Positivity for IgG1 IgG2, IgG3 and IgG4 subclasses will be determined using immunostaining with antibodies against IgG1 IgG2, IgG3 and IgG4, respectively, in glomeruli of kidney biopsy at inclusion. The positivity of tissue staining for PLA2R1, THSD7A and NELL-1or Ig subclasses will be correlated to the patient's clinical outcome one year after inclusion (complete remission, partial remission or persistent nephrotic syndrome, as defined under primary outcome measures).

    Measured: 12 months

Timeline

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

  1. First posted30 Mar 2020
  2. Study start4 Jul 2020
  3. Primary completion3 Jun 2031 (estimated)
  4. Study completion3 Dec 2031 (estimated)

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 N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
Descriptive analysis of patient cohort who will be subjected to specific samples related to the study
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04326218
Sponsor's protocol ID
18-GIRCI-03
Acronym
IHMN
Status last verified
Jun 2026
First submitted
26 Dec 2019
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No data will be shared

Publications

  • Cremoni M, Agbekodo S, Teisseyre M, Zorzi K, Brglez V, Benzaken S, Esnault V, Planchard JH, Seitz-Polski B. Toxic Occupational Exposures and Membranous Nephropathy. Clin J Am Soc Nephrol. 2022 Nov;17(11):1609-1619. doi: 10.2215/CJN.02930322. Epub 2022 Oct 25.

    PubMed 36283759

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample in people with Membranous Nephropathy, run by Centre Hospitalier Universitaire de Nice at 1 site 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Barbara SEITZ-POLSKI, MD (+33 4 92 03 55 02, seitz-polski.b@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the incidence of Membranous Nephropathy (MN) and its evolution (time frame: one year after inclusion). 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 NCT04326218, which also lists 1 linked publication.

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 16 Jun 2026.

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