Trial record 1 of 1 for:    NCT01859832
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Validation of a Novel Diagnostic Tool for the Evaluation of Post Renal Transplant Immunosuppression: The ImmuKnow Assay

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Patrick Luke, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01859832
First received: May 2, 2012
Last updated: August 31, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention
Renal Transplant Recipients
Other: Cylex ImmuKnow Assay

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of a Novel Diagnostic Tool for the Evaluation of Post Renal Transplant Immunosuppression: The ImmuKnow Assay

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Immune status [ Time Frame: A sample will be collected pre-transplant as well as for an expected average of 6 months post-transplant. ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained
Collected blood samples will be discarded immediately following testing

Enrollment: 19
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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."
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859832

Locations
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Astellas Pharma Canada, Inc.
Investigators
Principal Investigator: Patrick Luke, MD, FRCSC Lawson Health Research Institute
  More Information

Responsible Party: Patrick Luke, Dr. Patrick Luke, MD, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01859832     History of Changes
Other Study ID Numbers: R-09-016  15785E 
Study First Received: May 2, 2012
Last Updated: August 31, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
renal transplant
kidney transplantation
immune status
immunosuppressive medications

ClinicalTrials.gov processed this record on July 25, 2016