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Completed

NCT Number: NCT01443013

Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri Mondor Hospital

Créteil, 94010, France

About this 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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Transplant

Other

urinary sample at month 3, 6 and 12

Primary outcomes

  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 outcomes

  1. Renal biopsy

    Time frame: at Month 12

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: TUFEV

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 29, 2011
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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