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.

Study Overview

• Status: Completed
• Conditions: Renal Transplant Recipients
• Intervention / Treatment: Other: Cylex ImmuKnow Assay

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All participants enrolled in this study will be undergoing renal transplantation and will have already been 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."

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Astellas Pharma Canada, Inc.
• Investigators: Principal Investigator: Patrick Luke, MD, FRCSC, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: kidney transplantation; renal transplant; immune status; immunosuppressive medications
• Other Study ID Numbers: R-09-016; 15785E (Other Identifier: REB)