NCT01232816|Unknown
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?
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Can T Helper 17 and Regulatory T Cells Explain the Pathophysiology of Delayed Graft Function in Renal Transplant Recipients?
Sponsor study identifier
observational
50
1 country
1
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 30, 2010
Actual (reported)November 2, 2010
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Graft function
Kidney graft function as measured by GFR
1 year
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 kidney transplant recipients at our institution will be recruited prior to their operative procedure.
McGill University Health Center
Montreal, Quebec, H3A 1A1, Canada
Nguyen MT, Fryml E, Sahakian SK, Liu S, Cantarovich M, Lipman M, Tchervenkov JI, Paraskevas S. Pretransplant Recipient Circulating CD4+CD127lo/- Tumor Necrosis Factor Receptor 2+ Regulatory T Cells: A Surrogate of Regulatory T Cell-Suppressive Function and Predictor of Delayed and Slow Graft Function After Kidney Transplantation. Transplantation. 2016 Feb;100(2):314-24. doi: 10.1097/TP.0000000000000942.
Urine Kidney biopsy Kidney preservation fluid
Steven Paraskevas, MD PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre
First Submitted
October 30, 2010
First Posted
November 2, 2010
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Effect of Procrit (Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 14, 2016
Record last verified: 2016-09
There is no plan to make the experimental data available to participants. Their clinical data, however, is available to them through their treating physician.
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Source: ClinicalTrials.gov.
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