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Latent Tuberculosis Infection in Renal Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00682045
First Posted: May 21, 2008
Last Update Posted: June 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asan Medical Center
  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:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • development of tuberculosis [ Time Frame: within 2 years after transplantation ]

Secondary Outcome Measures:
  • all cause mortality [ Time Frame: within 2 years after transplantation ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 20, 2008
First Posted: May 21, 2008
Last Update Posted: June 2, 2010
Last Verified: March 2009

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