Validation of a Novel Diagnostic Tool for the Evaluation of Post Renal Transplant Immunosuppression: The ImmuKnow Assay
NCT ID: NCT01859832
Last Updated: 2015-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
19 participants
OBSERVATIONAL
2010-05-31
2013-12-31
Brief Summary
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This study is designed to evaluate an in vitro assay (Cylex®ImmuKnow Assay) for the measurement of cell-mediated immune response in renal transplant patients receiving immunosuppressive therapy. This assay measures ATP as an activation response of CD4+ cells to stimulation with phytohemagglutinin (PHA) in whole blood samples as a reflection of the immune system of the patient at any point in therapy. The natural history of the immune status of the renal transplant recipient as reflected by the ImmuKnow assay will be determined at specific time points of interest including: pre and post transplant, as an adjunct to therapeutic drug monitoring, and pre and post infectious or rejection episode. Analysis of the results of the assay at these time points will allow us to retrospectively study the effects of routine immunosuppressive agent modulation on immune function, and its subsequent effects in times of renal allograft insult.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Enrolled participants
All participants enrolled in this study will have been previously consented to the study entitled, "A Comparison of Effects of Standard Dose vs Low Dose Advagraf with Il-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB-based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response." This is an observational study with only one group/cohort in which all participants have bloodwork collected pre-transplant and at various time points post-transplant and these samples are analyzed using the Cylex ImmuKnow Assay.
Cylex ImmuKnow Assay
This is not an interventional study. However the assay being tested on the samples of all enrolled participants in the Cylex ImmuKnow Assay
Interventions
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Cylex ImmuKnow Assay
This is not an interventional study. However the assay being tested on the samples of all enrolled participants in the Cylex ImmuKnow Assay
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Astellas Pharma Canada, Inc.
INDUSTRY
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Patrick Luke
Dr. Patrick Luke, MD
Principal Investigators
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Patrick Luke, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Locations
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London Health Sciences Centre, University Hospital
London, Ontario, Canada
Countries
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Other Identifiers
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15785E
Identifier Type: OTHER
Identifier Source: secondary_id
R-09-016
Identifier Type: -
Identifier Source: org_study_id
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