Latent Tuberculosis Infection in Renal Transplant Recipients

N/ACompletedNCT00682045

Asan Medical Center240 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Renal Transplant

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

development of tuberculosis

Time frame: within 2 years after transplantation

Secondary Outcomes

all cause mortality

Time frame: within 2 years after transplantation

Data from ClinicalTrials.gov

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