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

This study is currently recruiting participants.
Verified July 2011 by McGill University Health Center
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01232816
First received: October 30, 2010
Last updated: August 2, 2011
Last verified: July 2011
History of Changes
  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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Biospecimen Retention:   Samples Without DNA

Urine Kidney biopsy Kidney preservation fluid


Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Delayed graft function
Immediate function

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232816

Contacts
Contact: Catherine Flemming 514-934-1934 ext 36569 catherine.flemming@muhc.mcgill.ca

Locations
Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Catherine Flemming     514-934-1934 ext 36569     catherine.flemming@muhc.mcgill.ca    
Principal Investigator: Steven Paraskevas, MD PhD            
Sponsors and Collaborators
McGill University Health Center
Hoffmann-La Roche
Investigators
Principal Investigator: Steven Paraskevas, MD PhD McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr. Steven Paraskevas, 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: August 2, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013