Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient

NCT01443013 | Completed DMC

• 2 other identifiers: NI08031AOM09031
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Function of Renal Transplant

Keywords

Tolerance; Renal Transplantation; Chronic allograft nephropathy

Outcome Measures

Primary Outcomes (1)

• Foxp3 and Vimentin mRNA expression

  evaluation at month 9 suppressed by amendment n°2

  at Month 1,3,6 and 12

Secondary Outcomes (1)

• Renal biopsy

  at Month 12

Study Arms (1)

Cohort of Renal Transplant recipients

Other: Renal Transplant

Interventions

Renal Transplant OTHER

urinary sample at month 3, 6 and 12

Cohort of Renal Transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Renal transplant recipients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

Related Publications (1)

• Aquino-Dias EC, Joelsons G, da Silva DM, Berdichevski RH, Ribeiro AR, Veronese FJ, Goncalves 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.

  PMID: 18216781 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine for mRNA extraction and congelation

MeSH Terms

Interventions

Kidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Philippe Grimbert, MD PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: September 29, 2011
• Study Start: September 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

FR (1)