Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04326218
Status:
UNKNOWN
Last Update Posted:
2020-04-07
First Post:
2019-12-26
Brief Title:
Immunopathological Analysis in a French National Cohort of Membranous Nephropathy
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Immunopathological Analysis in a French National Cohort of Membranous Nephropathy IHMN
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IHMN
Brief Summary:
National cohort of all cases of membranous nephropathy MN during a 1 year period in France based on a pathological andor 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None