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NCT00682045 Clinical Trial

Latent Tuberculosis Infection in Renal Transplant Recipients

Renal Transplant Clinical Trial

Official title:
A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00682045
Other study ID # AMC-20080169
Secondary ID
Status Completed
Phase N/A
First received May 20, 2008
Last updated June 1, 2010
Start date June 2008
Est. completion date May 2010

Study information
Verified date March 2009
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary development of tuberculosis within 2 years after transplantation Yes
Secondary all cause mortality within 2 years after transplantation Yes
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