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NCT02081729 Clinical Trial

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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02081729
Other study ID # 2014-0107
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 2014
Est. completion date August 2015

Study information
Verified date August 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 16 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Asan Medical Center Korea Advanced Institute of Science and Technology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary zoster development 6 months after transplantation
Secondary mortality 6 months after transplantation
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