Role of T Helper 17 and Regulatory T Cells in Delayed Graft Function
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| First Received Date ICMJE | October 30, 2010 | ||||
| Last Updated Date | August 2, 2011 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01232816 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Role of T Helper 17 and Regulatory T Cells in Delayed Graft Function | ||||
| Official Title ICMJE | Can T Helper 17 and Regulatory T Cells Explain the Pathophysiology of Delayed Graft Function in Renal Transplant Recipients? | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Urine Kidney biopsy Kidney preservation fluid |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | All kidney transplant recipients at our institution will be recruited prior to their operative procedure. |
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| Condition ICMJE | Delayed Graft Function | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01232816 | ||||
| Other Study ID Numbers ICMJE | 09-202-SDR | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Steven Paraskevas, McGill University Health Center | ||||
| Study Sponsor ICMJE | McGill University Health Center | ||||
| Collaborators ICMJE | Hoffmann-La Roche | ||||
| Investigators ICMJE |
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| Information Provided By | McGill University Health Center | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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