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Isoniazid (INH) Treatment Based on ELISPOT Assay

NCT ID: NCT01087190

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

831 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-11-30

Brief Summary

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It has been recommended that all transplant recipients undergo a tuberculin skin test (TST) before transplantation. However, the ability of TST to diagnose latent tuberculosis infection (LTBI) in transplant candidates has been reported to be suboptimal because of high rates of false-negative and false-positive results. The enzyme-linked immunospot assay (ELISPOT) detecting interferon-gamma secreting T-cells for diagnosing tuberculosis infection gave promising results in immunocompromised patients as well as in immunocompetent patients. The investigators will perform a randomized, open-label, prospective trial of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients.

Detailed Description

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Our previous data have shown that ELISPOT assay was more sensitive to detect LTBI in renal transplant recipients than TST (Kim SH, et al. Transplant Infect Dis 2010 Jan 25 \[Epub ahead of print\]). However, further studies are eagerly awaited to determine the efficacy of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients. All adult patients admitted for renal transplantation between May 2010 and April 2013 at the Asan Medical Center, Seoul, South Korea, will be prospectively enrolled. INH (300 mg/day for 9 months) prophylaxis group and no prophylaxis group (control group) will be randomly assigned to all patients with a baseline positive ELISPOT assay regardless of the results of TST. The investigators will compare cumulative probability of developing active TB after transplantation between INH prophylaxis group and control group as primary outcome. Secondary outcomes will be adverse drug reactions, rejection episodes, graft survival, and mortality.

Conditions

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Kidney Transplant Recipient

Keywords

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kidney transplantation tuberculosis ELISPOT isoniazid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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INH treatment group

* randomly allocated to INH treatment group in renal transplant recipients with ELISPOT (+)
* INH 300 mg po qd for 9 months

Group Type EXPERIMENTAL

Isoniazid treatment

Intervention Type DRUG

isoniazid 300 mg po qd for 9 months

Control group

* randomly allocated to control group in renal transplant recipients with ELISPOT (+)
* no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Observation group

* allocated to observation group in renal transplant recipients with ELISPOT (-)
* no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Isoniazid treatment

isoniazid 300 mg po qd for 9 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 16 years or more
* Kidney transplant recipients

Exclusion Criteria

* Patients who do not receive isoniazid treatment due to abnormal liver function (i.e. Child-Pugh Score B or C)
* Patients who have clinical risk factors for latent tuberculosis infection

1. Close contact with a person with pulmonary TB within the past year
2. Abnormal chest radiography and no prior prophylaxis
3. A history of untreated or inadequately treated TB
4. New infection (i.e. a recent conversion of TST to positive status)

* If kidney transplant donor has these clinical risk factors for latent tuberculosis infection, the transplant recipient from this donor will be excluded from this study.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sung-Han Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung-Han Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2010-0009

Identifier Type: -

Identifier Source: org_study_id