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Completed

NCT Number: NCT01897961

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anticorps anti-PLA2R1

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PRAM-KT

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2013
Registry last updated
Feb 12, 2024

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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