Latent Tuberculosis Infection in Renal Transplant Recipients - Full Text View

Sponsored by:	Asan Medical Center
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00682045

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

MedlinePlus related topics: Kidney Transplantation Tuberculosis

U.S. FDA Resources

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

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

Biospecimen Description:

peripheral blood mononuclear cells

Estimated Enrollment:	240
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	December 2009 (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

Contacts

Contact: Sung-Han Kim, MD

kimsunghanmd@hotmail.com

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sung-Han Kim, MD kimsunghanmd@hotmail.com

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator:

Sung-Han Kim, MD

Asan Medical Center

More Information

No publications provided

Responsible Party:	Asan Medical Center ( Sung-Han Kim, MD )
Study ID Numbers:	AMC-20080169
Study First Received:	May 20, 2008
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00682045 History of Changes
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:

tuberculosis
transplantation

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections

ClinicalTrials.gov processed this record on May 07, 2009