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Role of T Helper 17 and Regulatory T Cells in Delayed Graft Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01232816
First received: October 30, 2010
Last updated: August 2, 2011
Last verified: July 2011

October 30, 2010
August 2, 2011
July 2010
December 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01232816 on ClinicalTrials.gov Archive Site
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Role of T Helper 17 and Regulatory T Cells in Delayed Graft Function
Can T Helper 17 and Regulatory T Cells Explain the Pathophysiology of Delayed Graft Function in Renal Transplant Recipients?

Delayed graft function (DGF) increases risk of acute rejection after kidney transplantation (KTx). Interleukin-6, which is produced in DGF, is critical in directing naive T helper cells differentiation towards T helper 17 (Th17) and away from regulatory T (Treg) cells. The investigators hypothesize there is an increase in Th17 and a decrease in Treg expression in KTx recipients with DGF compared to those without, leading to immunologic consequences. The investigators will test their hypothesis by measuring in both groups expression of Th17, Treg, and related cytokines in blood, urine, kidney biopsy, and kidney preservation fluid, and correlating these results with immunologic events.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Urine Kidney biopsy Kidney preservation fluid

Non-Probability Sample

All kidney transplant recipients at our institution will be recruited prior to their operative procedure.

Delayed Graft Function
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  • Delayed graft function
  • Immediate function
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Kidney transplant recipients

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact: Catherine Flemming 514-934-1934 ext 36569 catherine.flemming@muhc.mcgill.ca
Canada
 
NCT01232816
09-202-SDR
No
Dr. Steven Paraskevas, McGill University Health Center
McGill University Health Center
Hoffmann-La Roche
Principal Investigator: Steven Paraskevas, MD PhD McGill University Health Center
McGill University Health Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP