Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient (TUFEV)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Function of Renal Transplant

Treatments: Other: Renal Transplant

Study type: Observational

Funder types: Other

Identifiers

NCT01443013

NI08031

AOM09031 (Other Identifier)

Details and patient eligibility

About

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.

Full 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,

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

266 participants in 1 patient group

Cohort of Renal Transplant recipients

Treatment:

Other: Renal Transplant