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Latent Tuberculosis Infection in Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00682045
First received: May 20, 2008
Last updated: June 1, 2010
Last verified: March 2009
History of Changes
  Purpose

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.


Condition
Renal Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Renal Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • development of tuberculosis [ Time Frame: within 2 years after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all cause mortality [ Time Frame: within 2 years after transplantation ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

peripheral blood mononuclear cells


Estimated Enrollment: 240
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
T-SPOT.TB positive
T-SPOT.TB positive patients

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

renal transplant recipients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682045

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Sung-Han Kim, MD Asan Medical Center
  More Information

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sung-Han Kim, MD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00682045     History of Changes
Other Study ID Numbers: AMC-20080169
Study First Received: May 20, 2008
Last Updated: June 1, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
tuberculosis
transplantation

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
 Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 16, 2013