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

Terminated

• Conditions: Kidney Transplantation

• Registration Number: NCT02081729
• Lead Sponsor: Asan Medical Center

Brief Summary

VZV is one of the important opportunistic infection in transplant recipients.Until now, there is no laboratory method to stratify the risk of VZV reactivation after solid organ transplantation. Theoretically, VZV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of VZV development after solid organ transplantation. The investigators thus evaluate the usefulness of VZV-specific ELISPOT assay in kidney transplant candidates to predict the development of VZV infection after kidney transplantation.

Detailed Description

We will develop VZV-specific ELISPOT assay, then perform this assay before transplantation. We will evaluate whether this assay will predict zoster reactivation after transplantation.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• age 16 years or more
• agree with written informed consent
• WBC count 2000/uL or more

Exclusion Criteria

• no exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
zoster development	6 months after transplantation

Secondary Outcome Measures

Name	Time	Method
mortality	6 months after transplantation

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of