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Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients (ACE-KT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02025335
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : September 25, 2015
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center

Brief Summary:
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.

Condition or disease
Kidney Transplantation Recipients

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.

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Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients (ACE-KT)
Study Start Date : March 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

high CMV ELISPOT results
high spot counts in ELISPOT
low CMV ELISPOT results
low spot counts in ELISPOT

Primary Outcome Measures :
  1. CMV infection [ Time Frame: 6 months after transplantation ]

    CMV infection is defined as follows.

    1. CMV viremia: CMV antigenemia or CMV quantitative PCR (+)
    2. CMV disease: CMV syndrome or tissue-invasive CMV disease i) CMV syndrome: ① CMV viremia ② temperature > 38 without other cause ③ WBC < 4000, atypical lymphocyte > 3%, transaminase elevation, platelet < 100,000/mm ii) tissue-invasive CMV disease: evidence of CMV in histopathologic specimen (inclusion body or viral antigen in biopsy or bronchoalveolar lavage fluid)

Secondary Outcome Measures :
  1. mortality [ Time Frame: 6 months after transplantation ]
  2. rejection [ Time Frame: 6 months after transplantation ]
  3. graft loss [ Time Frame: 6 months after transplantation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kindeny transplant recipients

Inclusion Criteria:

  • age 16 or more
  • agree with written informed consent

Exclusion Criteria:

  • donor CMV IgG (+) and recipient CMV IgG (-)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02025335

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
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Principal Investigator: Sung-Han Kim, MD Asan Medical Center

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Responsible Party: Sung-Han Kim, Associate Professor, Asan Medical Center Identifier: NCT02025335     History of Changes
Other Study ID Numbers: 2013-1040
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases