Renal Transplant Recipients Clinical Trial
Official title:
Validation of a Novel Diagnostic Tool for the Evaluation of Post Renal Transplant Immunosuppression: The ImmuKnow Assay
Patients undergoing renal transplantation at London Health Sciences Centre, University
Hospital and who are participating in the study "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" will be evaluated with the ImmuKnow Assay to assess the ability of this assay to
predict underimmunosuppression (rejection) or overimmunosuppression determined by this test
and to determine retrospectively whether decision making utilizing this novel assay would
have improved outcomes over standard techniques.
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.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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