Latent Tuberculosis Infection in Renal Transplant Recipients

NCT ID: NCT00682045

Last Updated: 2010-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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We evaluate the usefulness of a newly-developed T cell-based assay prior to undergoing immunosuppression in renal transplant recipients. Among all renal transplant recipients, patients with negative tuberculin skin test and no other indications for latent tuberculosis infection will be enrolled in this study. We will exam T-SPOT.TB test in these patients, and observe the developement of tuberculosis within 1 to 2 years after the transplantation. The results of T-SPOT.TB will be blinded to the investigators.

Conditions

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Renal Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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T-SPOT.TB positive

T-SPOT.TB positive patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Recent contact of patients with active pulmonary tuberculosis
* Suspected active tuberculosis
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Asan Medical Center

Principal Investigators

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Sung-Han Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 21749641 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20113458 (View on PubMed)

Other Identifiers

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AMC-20080169

Identifier Type: -

Identifier Source: org_study_id

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