Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient

Function of Renal Transplant Clinical Trial

— TUFEV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443013
• Other study ID #: NI08031
• Secondary ID: AOM09031
• Status: Completed
• Phase: N/A
• First received: August 9, 2011
• Last updated: October 18, 2015
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Function of Renal Transplant

Intervention

Other:
• Renal Transplant
urinary sample at month 3, 6 and 12

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Aquino-Dias EC, Joelsons G, da Silva DM, Berdichevski RH, Ribeiro AR, Veronese FJ, Gonçalves 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. Erratum in: Kidney Int. 2008 Aug;74(3):393. Veronose, F J V [corrected to Veronese, F J V]; Berdichewski, R H [corrected to Berdichevski, R H]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foxp3 and Vimentin mRNA expression	evaluation at month 9 suppressed by amendment n°2	at Month 1,3,6 and 12	No
Secondary	Renal biopsy		at Month 12	No