Latent Tuberculosis Infection in Renal Transplant Recipients | NCT00682045

Studies
Latent Tuberculosis Infection in Renal Transplant Recipients

NCT00682045

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jun 2, 2010Estimated

Enrollment

240Estimated

Phase

Not provided

Conditions

Renal Transplant

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

May 20, 2008

First Submission Date that Met QC Criteria

May 20, 2008

First Posted Date

May 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2010

Last Update Posted Date

Jun 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

240Estimated

Label	Type	Description	Intervention Names
T-SPOT.TB positive		T-SPOT.TB positive patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
development of tuberculosis		within 2 years after transplantation

Secondary Outcomes

Measure	Description	Time Frame
all cause mortality		within 2 years after transplantation

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

renal transplant recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sung-Han Kim, MD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		138-736	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21749641	Derived	Kim SH, Lee SO, Park JB, Park IA, Park SJ, Yun SC, Jung JH, Kim YH, Kim SC, Choi SH, Jeong JY, Kim YS, Woo JH, Park SK, Park JS, Han DJ. A prospective longitudinal study evaluating the usefulness of a T-cell-based assay for latent tuberculosis infection in kidney transplant recipients. Am J Transplant. 2011 Sep;11(9):1927-35. doi: 10.1111/j.1600-6143.2011.03625.x. Epub 2011 Jul 12.
20113458

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections