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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Dr. Steven Paraskevas, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01232816
First received: October 30, 2010
Last updated: April 6, 2015
Last verified: April 2015

October 30, 2010
April 6, 2015
July 2010
December 2018   (final data collection date for primary outcome measure)
Graft function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Kidney graft function as measured by GFR
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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.

All adult recipients of a primary kidney transplant will be eligible. Subjects will have blood samples drawn from which we will isolate lymphocytes and analyze the Treg population based on surface markers as well as a functional assay. The measures of Treg function will be compared to outcomes including DGF, graft survival and graft function, as well as the development of immunological complications such as donor-specific antibody production, acute rejection, IFTA and opportunistic infection.

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
    These are patients in whom dialysis is required following transplantation.
  • Immediate function
    These are patients in whom no dialysis is required and creatinine declines by >20% in the first 24 hours following transplantation.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2019
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Kidney transplant recipients

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01232816
09-202-SDR
No
Dr. Steven Paraskevas, McGill University Health Center
McGill University Health Center
Astellas Pharma Canada, Inc.
Principal Investigator: Steven Paraskevas, MD PhD McGill University Health Center
McGill University Health Center
April 2015

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