Isoniazid (INH) Treatment Based on ELISPOT Assay

Not Applicable

Completed

• Conditions: Kidney Transplant Recipient
• Interventions: Drug: Isoniazid treatment

• Registration Number: NCT01087190
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Study Start: 2010-06
• Primary Completion: 2013-05
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 831

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Development of tuberculosis (the rate of tuberculosis after transplantation)	3 years	Confirmed tuberculosis Probable tuberculosis Suspected or possible tuberculosis

Secondary Outcome Measures

Name	Time	Method
All cause deaths	3 years	* TB-associated deaths; * non-TB-associated deaths
INH-associated adverse drug reactions	3 years	liver function abnormalities
Graft failure	3 years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of