Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02025335

Acronym

ACE-KT

Enrollment

199

Registered

2014-01-01

Start date

2014-03-31

Completion date

2015-09-30

Last updated

2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation Recipients

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 90 Years

Healthy volunteers

Inclusion criteria

* age 16 or more * agree with written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
CMV infection	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

Measure	Time frame
mortality	6 months after transplantation
rejection	6 months after transplantation
graft loss	6 months after transplantation

Countries

South Korea

Outcome results