NCT02081729

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

March 5, 2014

Last Update Submit

August 28, 2018

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • zoster development

    6 months after transplantation

Secondary Outcomes (1)

  • mortality

    6 months after transplantation

Study Arms (2)

high VZV ELISPOT results

high spot counts in ELISPOT

low VZV ELISPOT results

low spot counts in ELISPOT

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kindeny transplant recipients

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Study Officials

  • Sung-Han Kim, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assocaite Professor

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

KR(1)