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

McGill University

Status: Unknown

Conditions: Delayed Graft Function

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01232816

09-202-SDR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney transplant recipients

Exclusion criteria

• None

Trial design

50 participants in 2 patient groups

Delayed graft function

Description:

These are patients in whom dialysis is required following transplantation.

Immediate function

Description:

These are patients in whom no dialysis is required and creatinine declines by \>20% in the first 24 hours following transplantation.