Clinical trial NCT01443013: Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient
Official title: Predictive Value Analysis of Messenger Ribonucleic Acid (mRNA) Urinary Expression of Foxp3 and Vimentin on Graft Outcome in Renal Transplant Recipient: National Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Function of Renal Transplant
Keywords: Tolerance
Renal Transplantation
Chronic allograft nephropathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Renal transplant recipients

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,

Eligibility criteria: 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

Primary outcomes:
measure: Foxp3 and Vimentin mRNA expression
timeFrame: at Month 1,3,6 and 12
Secondary outcomes:
measure: Renal biopsy
timeFrame: at Month 12
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Grimbert, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aquino-Dias EC, Joelsons G, da Silva DM, Berdichevski RH, Ribeiro AR, Veronese FJ, Goncalves LF, Manfro RC. Non-invasive diagnosis of acute rejection in kidney transplants with delayed graft function. Kidney Int. 2008 Apr;73(7):877-84. doi: 10.1038/sj.ki.5002795. Epub 2008 Jan 23.