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
  Purpose

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
Delayed Graft Function

Study Type: Observational
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?

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 50
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)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Kidney transplant recipients

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01232816

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

No publications provided

Responsible Party: Dr. Steven Paraskevas, Associate Professor of Surgery, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01232816     History of Changes
Other Study ID Numbers: 09-202-SDR
Study First Received: October 30, 2010
Last Updated: April 6, 2015
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes

ClinicalTrials.gov processed this record on August 31, 2015