NCT02025335|Completed
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients
ACE-KT
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ACE-KT
Sponsor study identifier
Secondary identifiers
observational
199
1 country
1
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2013
Actual (reported)January 1, 2014
Actual (reported)March 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 2015
Actual (reported)September 2015
Actual (reported)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
mortality
6 months after transplantation
rejection
6 months after transplantation
graft loss
6 months after transplantation
high spot counts in ELISPOT
low spot counts in ELISPOT
Kindeny transplant recipients
Asan Medical Center
Seoul, 138-736, South Korea
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.
Sung-Han Kim, MD
Asan Medical Center
199 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2013
First Posted
January 1, 2014
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%
Contact the study team to confirm eligibility.
Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)Last Updated
September 25, 2015
Record last verified: 2015-09
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Source: ClinicalTrials.gov.
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