NCT00682045

Brief Summary

The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients. For this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 2, 2010

Status Verified

March 1, 2009

Enrollment Period

1.9 years

First QC Date

May 20, 2008

Last Update Submit

June 1, 2010

Conditions

Renal Transplant

Keywords

tuberculosistransplantation

Outcome Measures

Primary Outcomes (1)

  • development of tuberculosis

    within 2 years after transplantation

Secondary Outcomes (1)

  • all cause mortality

    within 2 years after transplantation

Study Arms (1)

T-SPOT.TB positive

T-SPOT.TB positive patients

Eligibility Criteria

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

renal transplant recipients

You may qualify if:

  • Age 16 or more
  • Negative tuberculin skin test (induration less than 10 mm)

You may not qualify if:

  • Recent contact of patients with active pulmonary tuberculosis
  • Suspected active tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (2)

  • Kim SH, Lee SO, Park JB, Park IA, Park SJ, Yun SC, Jung JH, Kim YH, Kim SC, Choi SH, Jeong JY, Kim YS, Woo JH, Park SK, Park JS, Han DJ. A prospective longitudinal study evaluating the usefulness of a T-cell-based assay for latent tuberculosis infection in kidney transplant recipients. Am J Transplant. 2011 Sep;11(9):1927-35. doi: 10.1111/j.1600-6143.2011.03625.x. Epub 2011 Jul 12.

    PMID: 21749641DERIVED

  • Kim SH, Lee SO, Park IA, Park SJ, Choi SH, Kim YS, Woo JH, Park SK, Park JS, Kim SC, Han DJ. Diagnostic usefulness of a T cell-based assay for latent tuberculosis infection in kidney transplant candidates before transplantation. Transpl Infect Dis. 2010 Apr;12(2):113-9. doi: 10.1111/j.1399-3062.2010.00495.x. Epub 2010 Jan 25.

    PMID: 20113458DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cells

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

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

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 21, 2008

Study Start

June 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 2, 2010

Record last verified: 2009-03

Locations

KR(1)