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

National Taiwan University

Status and phase: Enrolling; Phase 4

Conditions: Pulmonology

Treatments: Drug: Rifamycin-containing regimen; Drug: Rifamycin-free regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT05588492

202110073MIND

Details and patient eligibility

About

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).

Full description

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). Therefore, we conducted this project aiming to monitor the safe issues (adverse events and drug-drug interaction), completion rate, and prevention effect in the population of KTRs.

Enrollment: 500 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Rifamycin containing regimen

Experimental group

Description:

Rifamycin containing regimen

Treatment:

Drug: Rifamycin-containing regimen

Rifamycin-free regimen

Experimental group

Description:

Rifamycin-free regimen

Treatment:

Drug: Rifamycin-free regimen