Back to resultsCell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
Primary Purpose
Transplant
Status
Completed
Phase
Locations
Canada
Study Type
Observational
Intervention
Monitoring-blood samples drawn for CMV testing
Sponsored by
About this trial
This is an observational trial for Transplant focused on measuring liver transplant, lung transplant, kidney transplant, heart transplant, CMV CMI
Eligibility Criteria
Inclusion Criteria:
Male or female patients who fulfill the following criteria are eligible for inclusion.
- CMV D+/R- liver, kidney and heart recipient
- CMV R+ liver,kidney and heart recipients who have received thymoglobulin induction therapy.
- D+/R- and R+ lung transplant recipients.
- Able to give written informed consent
- Are willing and able to comply with the protocol
- Age >=18 years
Exclusion Criteria:
- Patient unwilling or unable to give informed consent
Sites / Locations
- University Health Network
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00436384
First Posted
February 15, 2007
Last Updated
April 15, 2008
Sponsor
University Health Network, Toronto
Collaborators
The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00436384
Brief Title
Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
Official Title
Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
Study Type
Observational
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
The Physicians' Services Incorporated Foundation
4. Oversight
5. Study Description
Brief Summary
Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant
Keywords
liver transplant, lung transplant, kidney transplant, heart transplant, CMV CMI
7. Study Design
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Monitoring-blood samples drawn for CMV testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients who fulfill the following criteria are eligible for inclusion.
CMV D+/R- liver, kidney and heart recipient
CMV R+ liver,kidney and heart recipients who have received thymoglobulin induction therapy.
D+/R- and R+ lung transplant recipients.
Able to give written informed consent
Are willing and able to comply with the protocol
Age >=18 years
Exclusion Criteria:
Patient unwilling or unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Humar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deepali Kumar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
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