Clinical trial NCT01087190: Isoniazid (INH) Treatment Based on ELISPOT Assay
Official title: A Prospective, Randomized, Open Labeled Trial of Isoniazid Treatment Based on ELISPOT Assay to Prevent Tuberculosis in a Kidney Transplant Recipient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant Recipient
Keywords: kidney
transplantation
tuberculosis
ELISPOT
isoniazid
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 831
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Development of tuberculosis (the rate of tuberculosis after transplantation)
timeFrame: 3 years
Secondary outcomes:
measure: All cause deaths
timeFrame: 3 years
measure: INH-associated adverse drug reactions
timeFrame: 3 years
measure: Graft failure
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: