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RECRUITINGPhase 4INTERVENTIONAL

The Safety, Completion Rate and Prevention Effect by Rifamycin-containing Regimens for Latent Tuberculosis Infection in Patients With Kidney Transplantation: a Prospective Intervention Pilot Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Tuberculosis (TB) remains the leading infectious disease worldwide and kidney transplant recipients (KTR) is high risk population needing prevention from reactivation, which cause high mortality. In fact, its latent tuberculosis infection (LTBI) is increasing after transplantation and has been identified as a risk factor for TB. However, the suitable regimen for LTBI treatment in KTRs remains unclear. Currently, three-month rifamycin-containing regimens, such as weekly rifapentine and isoniazid (3HP) or daily rifampicin and isoniazid (3HP), are common because its non-inferiority to nine-month of daily isoniazid (9H) and high completion rate by its short course in TB contacts. However, KTRs have many differences from general population, like use of immune-suppressants and possible residual renal insufficiency, so that to prescribe rifamycin-containing LTBI treatment regimens may have many concerns. One biggest concern is that drug-drug interaction between rifamycin and immunosuppressants. In addition, there is no study before in investigating the use of rifamycin-containing regimen in the population of KTRs (only study for kidney transplant candidates).

Who May Be Eligible (Plain English)

Who May Qualify: 1. Received kidney transplant, and 2. Will receive interferon-gamma release assay (IGRA) for LTBI, and 3. If IGRA was positive, participants agree to receive LTBI treatment Who Should NOT Join This Trial: 1. Age \< 20 years old 2. pregnancy 3. Suspicious active tuberculosis Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Received kidney transplant, and 2. Will receive interferon-gamma release assay (IGRA) for LTBI, and 3. If IGRA was positive, participants agree to receive LTBI treatment Exclusion Criteria: 1. Age \< 20 years old 2. pregnancy 3. Suspicious active tuberculosis

Treatments Being Tested

DRUG

Rifamycin-containing regimen

Rifamycin-containing regimen

DRUG

Rifamycin-free regimen

Rifamycin-free regimen

Locations (1)

National Taiwan University Hospital
Taipei, Taiwan