Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient

Study Overview
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Brief Summary
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This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.

Detailed Description
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This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function,

Official Title
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Predictive Value Analysis of Messenger Ribonucleic Acid (mRNA) Urinary Expression of Foxp3 and Vimentin on Graft Outcome in Renal Transplant Recipient: National Prospective Study

Conditions
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Function of Renal Transplant

Intervention / Treatment
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* Other: Renal Transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All renal transplant recipients aged >18 years with informed consent Kidney transplantation in one of the centers participating in the study all patients registered on the waiting list to the Agency of Biomedicine Supported by a conventional procedure Informed consent signed. No pregnancy or lactation in progress. Serology HIV and (HCV negative suppressed by amendment n°2) No contraindication for a biopsy at 1 year post transplant Exclusion Criteria: Positive crossmatch, focal segmental glomerulosclerosis (FSGS) as primary nephropathy, HIV positive population Absence of registration on the waiting list for transplantation with the Agency of Biomedicine HIV-positive serology Chronic renal failure secondary to focal segmental hyalinosis Cross-match historical or cross match of the day positive T or B awareness Patient included in a Memorandum of industry (suppressed by amendment n°1) No affiliation to a social security scheme Patients with early failure due to immediate complications (4%) will be included but will not be considered for analysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort of Renal Transplant recipients<br> | Other: Renal Transplant<br>* urinary sample at month 3, 6 and 12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foxp3 and Vimentin mRNA expression | evaluation at month 9 suppressed by amendment n°2 | at Month 1,3,6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal biopsy |  | at Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolerance, Renal Transplantation, Chronic allograft nephropathy