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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01443013
First received: August 9, 2011
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Function of Renal Transplant
Other: Renal Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Foxp3 and Vimentin mRNA expression [ Time Frame: at Month 1,3,6 and 12 ] [ Designated as safety issue: No ]
    evaluation at month 9 suppressed by amendment n°2


Secondary Outcome Measures:
  • Renal biopsy [ Time Frame: at Month 12 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine for mRNA extraction and congelation


Estimated Enrollment: 500
Study Start Date: September 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort of Renal Transplant recipients Other: Renal Transplant
urinary sample at month 3, 6 and 12
Other Name: Renal Transplant

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All Renal transplant recipients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443013

Contacts
Contact: Philippe Grimbert, MD PHD (0)149812460 ext +33 philippe.grimbert@hmn.aphp.fr
Contact: Fayrouz Martina, CRA 1 49 81 33 89 ext +33 fayrouz.martina@hmn.aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Philippe Grimbert, MD PHD    (0)149812460 ext +33    philippe.grimbert@hmn.aphp.fr   
Contact: Fayrouz Martina, CRA    1 49 81 33 89 ext +33    fayrouz.martina@hmn.aphp.fr   
Principal Investigator: Philippe Grimbert, MD PHD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe Grimbert, MD PHD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01443013     History of Changes
Other Study ID Numbers: NI08031, AOM09031
Study First Received: August 9, 2011
Last Updated: August 1, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Tolerance
Renal Transplantation
Chronic allograft nephropathy

ClinicalTrials.gov processed this record on October 19, 2014