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Isoniazid (INH) Treatment Based on ELISPOT Assay

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ClinicalTrials.gov Identifier: NCT01087190
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Recipient Drug: Isoniazid treatment Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 831 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open Labeled Trial of Isoniazid Treatment Based on ELISPOT Assay to Prevent Tuberculosis in a Kidney Transplant Recipient
Study Start Date : June 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Isoniazid

Arms and Interventions
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Arm Intervention/treatment
Experimental: INH treatment group
  • randomly allocated to INH treatment group in renal transplant recipients with ELISPOT (+)
  • INH 300 mg po qd for 9 months
 Drug: Isoniazid treatment
isoniazid 300 mg po qd for 9 months
No Intervention: Control group
  • randomly allocated to control group in renal transplant recipients with ELISPOT (+)
  • no treatment
No Intervention: Observation group
  • allocated to observation group in renal transplant recipients with ELISPOT (-)
  • no treatment


Outcome Measures
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Primary Outcome Measures :
  1. Development of tuberculosis (the rate of tuberculosis after transplantation) [ Time Frame: 3 years ]
    Confirmed tuberculosis Probable tuberculosis Suspected or possible tuberculosis


Secondary Outcome Measures :
  1. All cause deaths [ Time Frame: 3 years ]
    • TB-associated deaths
    • non-TB-associated deaths

  2. INH-associated adverse drug reactions [ Time Frame: 3 years ]
    liver function abnormalities

  3. Graft failure [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT01087190


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Sung-Han Kim, MD Asan Medical Center
More Information
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Responsible Party: Sung-Han Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01087190    
Other Study ID Numbers: 2010-0009
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Keywords provided by Sung-Han Kim, Asan Medical Center:
kidney
transplantation
tuberculosis
ELISPOT
isoniazid
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Isoniazid
Antitubercular Agents
 Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents