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NCT01232816 Clinical Trial

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

Delayed Graft Function Clinical Trial

Official title:
Can T Helper 17 and Regulatory T Cells Explain the Pathophysiology of Delayed Graft Function in Renal Transplant Recipients?

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01232816
Other study ID # 09-202-SDR
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 30, 2010
Last updated September 12, 2016
Start date July 2010
Est. completion date December 2019

Study information
Verified date September 2016
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Kidney transplant recipients

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada McGill University Health Center Montreal Quebec

Sponsors (2)
Lead Sponsor Collaborator
McGill University Health Center Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Graft function Kidney graft function as measured by GFR 1 year No
See also
  Status Clinical Trial Phase
Withdrawn NCT02312115 - Delayed Renal Allograft Function and Furosemide Treatment Phase 2
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Completed NCT02346968 - Evaluation of CAF22 After Renal Transplantation
Completed NCT01794663 - Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function Phase 2
Completed NCT00298181 - YSPSL for Prevention of Delayed Graft Function Part A Phase 1/Phase 2
Not yet recruiting NCT05166460 - Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation N/A
Recruiting NCT03071536 - Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation N/A
Not yet recruiting NCT05513807 - Graft Acute Kidney Injury: Vitamin B3 to Facilitate Renal Recovery In the Early Life of a Transplant Phase 3
Recruiting NCT04005469 - Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation Phase 1/Phase 2
Completed NCT01848249 - Deceased Donor Biomarkers and Recipient Outcomes
Active, not recruiting NCT02474667 - Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney Phase 3
No longer available NCT02026934 - CliniMACS® CD34+ Reagent System for Expanded Access Use N/A
Terminated NCT00217152 - A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors Phase 4
Recruiting NCT05430620 - Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys Phase 3
Completed NCT03864926 - Envarsus in Delayed Graft Function (E-DGF) Phase 4
Recruiting NCT06367205 - Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations N/A
Completed NCT02610296 - QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant Phase 3
Active, not recruiting NCT02568696 - Intra-graft Coagulation Events in Clinical Renal Transplantation and Delayed Graft Function
Recruiting NCT01837043 - Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function Phase 2
Terminated NCT01878786 - A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys Phase 2/Phase 3