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

October 18, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Renal transplant recipients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal biopsy
Time Frame: at Month 12
at Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Philippe Grimbert, MD PHD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 18, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NI08031
  • AOM09031 (Other Identifier: Other sponsor number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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