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

Asan Medical Center

Status: Completed

Conditions: Kidney Transplantation Recipients

Study type: Observational

Funder types: Other

Identifiers

NCT02025335

2013-1040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 199 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 16 or more
• agree with written informed consent

Exclusion criteria

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

Trial design

199 participants in 2 patient groups

high CMV ELISPOT results

Description:

high spot counts in ELISPOT

low CMV ELISPOT results

Description:

low spot counts in ELISPOT