We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01232816
First Posted: November 2, 2010
Last Update Posted: September 14, 2016
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.
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Dr. Steven Paraskevas, McGill University Health Center
  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 Dr. Steven Paraskevas, McGill University Health Center:

Primary Outcome Measures:
  • Graft function [ Time Frame: 1 year ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

Inclusion Criteria:

  • Kidney transplant recipients

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: October 30, 2010
First Posted: November 2, 2010
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