This trial is active, not recruiting.

Condition delayed graft function
Sponsor McGill University Health Center
Collaborator Astellas Pharma Canada, Inc.
Start date July 2010
End date December 2018
Trial size 50 participants
Trial identifier NCT01232816, 09-202-SDR


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
These are patients in whom dialysis is required following transplantation.
These are patients in whom no dialysis is required and creatinine declines by >20% in the first 24 hours following transplantation.

Primary Outcomes

Graft function
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Kidney transplant recipients Exclusion Criteria:

Additional Information

Official title Can T Helper 17 and Regulatory T Cells Explain the Pathophysiology of Delayed Graft Function in Renal Transplant Recipients?
Principal investigator Steven Paraskevas, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by McGill University Health Center.