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

Kidney Transplantation Clinical Trial

— PRAM-KT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897961
• Other study ID #: 2011-A01302-39
• Status: Completed
• Phase: N/A
• Start date: January 10, 2012
• Est. completion date: March 3, 2018

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: March 3, 2018
• Est. primary completion date: March 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Kidney Transplantation

Intervention

Other:
• Anticorps anti-PLA2R1

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine the value forecast of the presence of antibody anti-PLA2R1	to determine the value forecast of the presence of antibody anti-PLA2R1 by the reference method for the second offenseof idiopathic or secondary GEM	Change from baseline the presence of antibody anti-PLA2R1 at 3 month and 6 month