Phospholipase A2 Receptor (PLA2R1) Autoantibodies in Membranous Nephropathy in Kidney Transplantation (PRAM-KT)
Primary Purpose
Kidney Transplantation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anticorps anti-PLA2R1
Sponsored by
About this trial
This is an interventional diagnostic trial for Kidney Transplantation
Eligibility 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
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Patients whose renal disease of origin is a GEM
Transplanted Patients of origin is a GEM having done it again
Transplanted patients, and having developed a GEM of novo
Arm Description
Patients whose renal disease of origin is a GEM
Transplanted Patients of origin is a GEM having done it again
Transplanted patients, and having developed a GEM of novo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01897961
First Posted
July 20, 2012
Last Updated
July 10, 2013
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01897961
Brief Title
Phospholipase A2 Receptor (PLA2R1) Autoantibodies in Membranous Nephropathy in Kidney Transplantation
Acronym
PRAM-KT
Official Title
Phospholipase A2 Receptor (PLA2R1) Autoantibodies in Membranous Nephropathy in Kidney Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients whose renal disease of origin is a GEM
Arm Type
Other
Arm Description
Patients whose renal disease of origin is a GEM
Arm Title
Transplanted Patients of origin is a GEM having done it again
Arm Type
Other
Arm Description
Transplanted Patients of origin is a GEM having done it again
Arm Title
Transplanted patients, and having developed a GEM of novo
Arm Type
Other
Arm Description
Transplanted patients, and having developed a GEM of novo
Intervention Type
Other
Intervention Name(s)
Anticorps anti-PLA2R1
Primary Outcome Measure Information:
Title
to determine the value forecast of the presence of antibody anti-PLA2R1
Description
to determine the value forecast of the presence of antibody anti-PLA2R1 by the reference method for the second offenseof idiopathic or secondary GEM
Time Frame
Change from baseline the presence of antibody anti-PLA2R1 at 3 month and 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent ESNAULT, Pr
Phone
04 92 03 88 76
Ext
0033
Email
esnault.v@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent ESNAULT, Pr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Esnault, Pr
Phone
04 92 03 88 76
Email
esnault.v@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Vincent ESNAULT, Pr
12. IPD Sharing Statement
Citations:
PubMed Identifier
31340979
Citation
Seitz-Polski B, Dahan K, Debiec H, Rousseau A, Andreani M, Zaghrini C, Ticchioni M, Rosenthal A, Benzaken S, Bernard G, Lambeau G, Ronco P, Esnault VLM. High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy. Clin J Am Soc Nephrol. 2019 Aug 7;14(8):1173-1182. doi: 10.2215/CJN.11791018. Epub 2019 Jul 24.
Results Reference
derived
PubMed Identifier
26296473
Citation
Seitz-Polski B, Dolla G, Payre C, Tomas NM, Lochouarn M, Jeammet L, Mariat C, Krummel T, Burtey S, Courivaud C, Schlumberger W, Zorzi K, Benzaken S, Bernard G, Esnault VL, Lambeau G. Cross-reactivity of anti-PLA2R1 autoantibodies to rabbit and mouse PLA2R1 antigens and development of two novel ELISAs with different diagnostic performances in idiopathic membranous nephropathy. Biochimie. 2015 Nov;118:104-15. doi: 10.1016/j.biochi.2015.08.007. Epub 2015 Aug 19.
Results Reference
derived
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Phospholipase A2 Receptor (PLA2R1) Autoantibodies in Membranous Nephropathy in Kidney Transplantation
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