Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients
ACE-KT
1 other identifier
observational
199
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 1, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 25, 2015
September 1, 2015
1.5 years
December 16, 2013
September 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
CMV infection
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)
6 months after transplantation
Secondary Outcomes (3)
mortality
6 months after transplantation
rejection
6 months after transplantation
graft loss
6 months after transplantation
Study Arms (2)
high CMV ELISPOT results
high spot counts in ELISPOT
low CMV ELISPOT results
low spot counts in ELISPOT
Eligibility Criteria
Kindeny transplant recipients
You may qualify if:
- age 16 or more
- agree with written informed consent
You may not qualify if:
- donor CMV IgG (+) and recipient CMV IgG (-)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (1)
Kim T, Lee HJ, Kim SM, Jung JH, Shin S, Kim YH, Sung H, Chong YP, Lee SO, Choi SH, Kim YS, Woo JH, Kim SH, Han DJ. Diagnostic usefulness of the cytomegalovirus (CMV)-specific T cell-based assay for predicting CMV infection after kidney transplant. Korean J Intern Med. 2020 Mar;35(2):438-448. doi: 10.3904/kjim.2017.318. Epub 2018 Jun 7.
PMID: 29865778DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sung-Han Kim, MD
Asan Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 16, 2013
First Posted
January 1, 2014
Study Start
March 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 25, 2015
Record last verified: 2015-09