NCT04326218

Brief 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 remission or persistent nephrotic syndrome)
  • environmental risk factors for the onset of MN
  • HLA markers
  • patient care status in France

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
65mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jul 2020Dec 2031

First Submitted

Initial submission to the registry

December 26, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 4, 2020

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2031

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2031

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

10.9 years

First QC Date

December 26, 2019

Last Update Submit

June 15, 2026

Conditions

Membranous Nephropathy

Outcome Measures

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)

    one year after inclusion

Secondary Outcomes (6)

  • Determination of incidence of primary and secondary forms of MN

    24 months

  • Identification of environmental factors associated with the onset of MN

    24 months

  • Description of the standard of care for patients with MN in France

    24 months

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

    24 months

  • Characterization of HLA typing of MN patients

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Cohort

OTHER

All patients included will have to be taken blood samples

Other: Blood sample

Interventions

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

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice, Hôpital de l'Archet

Nice, Alpes Maritime, 06200, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36283759DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Barbara Seitz-polski

    Hopital de l'Archet laboratoire immunology, 151 route de sain-Antoine de Ginestière 06200 Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara SEITZ-POLSKI, MD

CONTACT

+33 4 92 03 55 02seitz-polski.b@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Descriptive analysis of patient cohort who will be subjected to specific samples related to the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2019

First Posted

March 30, 2020

Study Start

July 4, 2020

Primary Completion (Estimated)

June 3, 2031

Study Completion (Estimated)

December 3, 2031

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

No data will be shared

Locations

FR(1)