Role of T Helper 17 and Regulatory T Cells in Delayed Graft Function
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.
Delayed Graft Function
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Can T Helper 17 and Regulatory T Cells Explain the Pathophysiology of Delayed Graft Function in Renal Transplant Recipients?|
- Graft function [ Time Frame: 1 year ] [ Designated as safety issue: No ]Kidney graft function as measured by GFR
Biospecimen Retention: Samples Without DNA
Urine Kidney biopsy Kidney preservation fluid
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Delayed graft function
These are patients in whom dialysis is required following transplantation.
These are patients in whom no dialysis is required and creatinine declines by >20% in the first 24 hours following transplantation.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232816
|McGill University Health Center|
|Montreal, Quebec, Canada, H3A 1A1|
|Principal Investigator:||Steven Paraskevas, MD PhD||McGill University Health Center|