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NCT Number: NCT01087190

Isoniazid (INH) Treatment Based on ELISPOT Assay

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.

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Key information

Conditions

Kidney Transplant Recipient Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Close contact with a person with pulmonary TB within the past year
  • Abnormal chest radiography and no prior prophylaxis
  • A history of untreated or inadequately treated TB
  • 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.

Treatment and study plan

Isoniazid treatment

Drug

isoniazid 300 mg po qd for 9 months

Primary outcomes

  1. Development of tuberculosis (the rate of tuberculosis after transplantation)

    Time frame: 3 years

    Confirmed tuberculosis Probable tuberculosis Suspected or possible tuberculosis

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

A Prospective, Randomized, Open Labeled Trial of Isoniazid Treatment Based on ELISPOT Assay to Prevent Tuberculosis in a Kidney Transplant Recipient

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 16, 2010
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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