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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01232816
Recruitment Status : Active, not recruiting
First Posted : November 2, 2010
Last Update Posted : September 14, 2016
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Dr. Steven Paraskevas, McGill University Health Center

Brief Summary:
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.

Condition or disease
Delayed Graft Function

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 50 participants
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?
Study Start Date : July 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

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.

Primary Outcome Measures :
  1. Graft function [ Time Frame: 1 year ]
    Kidney graft function as measured by GFR

Biospecimen Retention:   Samples Without DNA
Urine Kidney biopsy Kidney preservation fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All kidney transplant recipients at our institution will be recruited prior to their operative procedure.

Inclusion Criteria:

  • Kidney transplant recipients

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01232816

Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Astellas Pharma Canada, Inc.
Principal Investigator: Steven Paraskevas, MD PhD McGill University Health Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Steven Paraskevas, Associate Professor of Surgery, McGill University Health Center Identifier: NCT01232816     History of Changes
Other Study ID Numbers: 09-202-SDR
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make the experimental data available to participants. Their clinical data, however, is available to them through their treating physician.

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes