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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by McGill University Health Center.
Recruitment status was  Recruiting
Hoffmann-La Roche
Information provided by:
McGill University Health Center Identifier:
First received: October 30, 2010
Last updated: August 2, 2011
Last verified: July 2011

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.

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:

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)
Delayed graft function
Immediate function


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.


Inclusion Criteria:

  • Kidney transplant recipients

Exclusion Criteria:

  • None
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01232816

Contact: Catherine Flemming 514-934-1934 ext 36569

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

No publications provided

Responsible Party: Dr. Steven Paraskevas, McGill University Health Center 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 processed this record on March 25, 2015