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Phospholipase A2 Receptor (PLA2R1) Autoantibodies in Membranous Nephropathy in Kidney Transplantation (PRAM-KT)

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ClinicalTrials.gov Identifier: NCT01897961
Recruitment Status : Unknown
Verified July 2012 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : July 12, 2013
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

The Membranous nephropathy (GEM)idiopatic is the most frequent cause of syndrome néphrotique at the adult and represent approximately 2 % of the causes of terminal chronic renal insufficiency. A etiology balance assessment must be systematically realized to eliminate a secondary cause. Antibodies managed against the receiver of phospholipases A2 secreted by type M (PLA2R1) was recently detected in a population of GEM idiopatic, but not secondary GEM. PLA2R1 is expressed by the podocytes of the glomerules of healthy subjects, and this receiver co-is located with the deposits of extramembraneous IgG of the expanding subjects of idiopathique GEM. The good IgG the extramembraneous depositsof GEM idiopathic recognize PLA2R1. At some patients, the activity anti-PLA2R1 seems to decrease or to disappear during the stake in forgiveness of the disease.

Some cases of second offense of GEM idiopathique after renal transplantation presenting antibodies anti-PLA2R1 have also described. The appearance of antibody anti-PLA2R1 seems parallel to the increase of a proteinurie in touch with a second offense of GEM, and antibodies sometimes disappeared after a therapeutic strengthening by Rituximab allowing to obtain a forgiveness.

A GEM can also appear of novo on the renal transplant, it is to say without notion of GEM on the native loins. The physiopathology of this affection remains unknown.

Working hypothesis and objectives We shall look in which proportion the presence of antibody anti-PLA2R1 is associated with the second offense of GEM idiopathic in renal transplantation. We anticipate that the GEM of novo of the renal transplant answers a different physiopathology, and will not be associated with the presence of antibody anti-PLA2R1. We hope to demonstrate that at the expanding patients of antibody anti-PLA2R1, the title of these antibodies is correlated in the activity of the disease and in the renal survival, and that the longitudinal follow-up of the title of these antibodies has an interest forecast and therapeutics.


Condition or disease Intervention/treatment Phase
Kidney Transplantation Other: Anticorps anti-PLA2R1 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phospholipase A2 Receptor (PLA2R1) Autoantibodies in Membranous Nephropathy in Kidney Transplantation
Study Start Date : March 2012
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015


Arm Intervention/treatment
Patients whose renal disease of origin is a GEM
Patients whose renal disease of origin is a GEM
Other: Anticorps anti-PLA2R1
Transplanted Patients of origin is a GEM having done it again
Transplanted Patients of origin is a GEM having done it again
Other: Anticorps anti-PLA2R1
Transplanted patients, and having developed a GEM of novo
Transplanted patients, and having developed a GEM of novo
Other: Anticorps anti-PLA2R1



Primary Outcome Measures :
  1. to determine the value forecast of the presence of antibody anti-PLA2R1 [ Time Frame: Change from baseline the presence of antibody anti-PLA2R1 at 3 month and 6 month ]
    to determine the value forecast of the presence of antibody anti-PLA2R1 by the reference method for the second offenseof idiopathic or secondary GEM



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of 18 or more years old,
  • Presenting one of the following three profiles:
  • Group 1: patients whose renal disease of origin is a GEM, and

    • or 1a: that must receive a renal transplantation, or transplanted for less than three months and having a day serum of the transplantation available on the laboratory of immunology or virology,
    • or 1b: transplanted for more than three months, not having done it again a GEM yet, and having a day serum of the transplantation available on the laboratory of immunology or virology.
  • Group 2: transplanted patients whose renal disease of origin is a GEM, having done it again a GEM on their renal transplant, and having an available serum the day of the transplantation and of the diagnosis of second offense of GEM in the laboratory of immunology or virology.
  • Group 3: transplanted patients, and having developed a GEM of novo, and having an available serum the day of the transplantation and of the diagnosis of GEM of novo in the laboratory of immunology or virology.

Exclusion Criteria:

  • vulnerable person

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897961


Contacts
Contact: Vincent ESNAULT, Pr 04 92 03 88 76 ext 0033 esnault.v@chu-nice.fr

Locations
France
CHU de Nice Recruiting
Nice, France, 06000
Contact: Vincent Esnault, Pr    04 92 03 88 76    esnault.v@chu-nice.fr   
Principal Investigator: Vincent ESNAULT, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Vincent ESNAULT, Pr Centre Hospitalier Universitaire de Nice

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01897961     History of Changes
Other Study ID Numbers: 2011-A01302-39
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: July 2012

Additional relevant MeSH terms:
Glomerulonephritis, Membranous
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs