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

NCT01232816 | Unknown

• 1 other identifier: 09-202-SDR
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delayed Graft Function

Outcome Measures

Primary Outcomes (1)

• Graft function

  Kidney graft function as measured by GFR

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All kidney transplant recipients at our institution will be recruited prior to their operative procedure.

You may qualify if:

• Kidney transplant recipients

You may not qualify if:

• None

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Astellas Pharma Canada, Inc.: collaborator

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

• Nguyen MT, Fryml E, Sahakian SK, Liu S, Cantarovich M, Lipman M, Tchervenkov JI, Paraskevas S. Pretransplant Recipient Circulating CD4+CD127lo/- Tumor Necrosis Factor Receptor 2+ Regulatory T Cells: A Surrogate of Regulatory T Cell-Suppressive Function and Predictor of Delayed and Slow Graft Function After Kidney Transplantation. Transplantation. 2016 Feb;100(2):314-24. doi: 10.1097/TP.0000000000000942.

  PMID: 26425877 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Kidney biopsy Kidney preservation fluid

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Paraskevas, MD PhD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: October 30, 2010
• First Posted: November 2, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)