Immunopathological Analysis in a French National Cohort of Membranous Nephropathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Blood sample

    Other intervention

    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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: CohortOther 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
one year after inclusion

Secondary outcomes

1

Determination of incidence of primary and secondary forms of MN

Time frame
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

Time frame
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

Time frame
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.

Time frame
24 months

Other outcomes

Sponsors and contacts

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