Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01443013

Acronym

TUFEV

Enrollment

266

Registered

2011-09-29

Start date

2010-09-30

Completion date

2015-01-31

Last updated

2015-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Function of Renal Transplant

Keywords

Tolerance, Renal Transplantation, Chronic allograft nephropathy

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

Interventions

OTHERRenal Transplant

urinary sample at month 3, 6 and 12

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Renal biopsy	at Month 12

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026