Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient

Completed

• Conditions: Function of Renal Transplant
• Interventions: Other: Renal Transplant

• Registration Number: NCT01443013
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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,

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-18
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of Renal Transplant recipients	Renal Transplant	-

Primary Outcome Measures

Name	Time	Method
Foxp3 and Vimentin mRNA expression	at Month 1,3,6 and 12	evaluation at month 9 suppressed by amendment n°2

Secondary Outcome Measures

Name	Time	Method
Renal biopsy	at Month 12

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France