Validation of a Novel Diagnostic Tool for the Evaluation of Post Renal Transplant Immunosuppression: The ImmuKnow Assay

Completed

• Conditions: Renal Transplant Recipients
• Interventions: Other: Cylex ImmuKnow Assay

• Registration Number: NCT01859832
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Patients undergoing implantation surgery for renal transplantation at London Health Sciences Centre, University Hospital
• Patients who have 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"

Exclusion Criteria

Exclusion Criteria:

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled participants	Cylex ImmuKnow Assay	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.

Primary Outcome Measures

Name	Time	Method
Immune status	A sample will be collected pre-transplant as well as for an expected average of 6 months post-transplant.

Trial Locations

Locations (1)

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada