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

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ClinicalTrials.gov Identifier: NCT01443013
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Function of Renal Transplant Other: 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,

Study Design

Study Type : Observational
Actual Enrollment : 266 participants
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
Study Start Date : September 2010
Primary Completion Date : December 2014
Study Completion Date : January 2015

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Cohort of Renal Transplant recipients Other: Renal Transplant
urinary sample at month 3, 6 and 12


Outcome Measures

Primary Outcome Measures :
  1. Foxp3 and Vimentin mRNA expression [ Time Frame: at Month 1,3,6 and 12 ]
    evaluation at month 9 suppressed by amendment n°2


Secondary Outcome Measures :
  1. Renal biopsy [ Time Frame: at Month 12 ]

Biospecimen Retention:   Samples Without DNA
Urine for mRNA extraction and congelation

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443013


Locations
France
Henri Mondor Hospital
Creteil, France, 94010
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 ( Other Identifier: Other sponsor number )
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

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