- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025335
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients (ACE-KT)
September 24, 2015 updated by: Sung-Han Kim, Asan Medical Center
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients (ACE-KT)
CMV is one of the most important opportunistic infection in transplant recipients.
In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG.
Until now, sero-positivity for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation.
Theoretically, CMV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of CMV development after solid organ transplantation.
The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant candidates to predict the development of CMV infection after kidney transplantation.
Study Overview
Status
Completed
Conditions
Detailed Description
Between Mar 2014 and Mar 2015, all patients admitted in the kidney transplant unit will be enrolled in this study.
All patients will receive CMV-specific ELISPOT assay and be prospectively followed for the development of CMV infection.
Study Type
Observational
Enrollment (Actual)
199
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Kindeny transplant recipients
Description
Inclusion Criteria:
- age 16 or more
- agree with written informed consent
Exclusion Criteria:
- donor CMV IgG (+) and recipient CMV IgG (-)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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high CMV ELISPOT results
high spot counts in ELISPOT
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low CMV ELISPOT results
low spot counts in ELISPOT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CMV infection
Time Frame: 6 months after transplantation
|
CMV infection is defined as follows.
|
6 months after transplantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mortality
Time Frame: 6 months after transplantation
|
6 months after transplantation
|
rejection
Time Frame: 6 months after transplantation
|
6 months after transplantation
|
graft loss
Time Frame: 6 months after transplantation
|
6 months after transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
December 16, 2013
First Submitted That Met QC Criteria
December 30, 2013
First Posted (Estimate)
January 1, 2014
Study Record Updates
Last Update Posted (Estimate)
September 25, 2015
Last Update Submitted That Met QC Criteria
September 24, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-1040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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