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

Phase 4

Recruiting

• Conditions: Pulmonology
• Interventions: Drug: Rifamycin-free regimen; Drug: Rifamycin-containing regimen

• Registration Number: NCT05588492
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-04
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-10-18
• Last Update Submitted: 2022-10-18
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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Exclusion Criteria

1. Age < 20 years old
2. pregnancy
3. Suspicious active tuberculosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Rifamycin-free regimen	Rifamycin-free regimen	Rifamycin-free regimen
Rifamycin containing regimen	Rifamycin-containing regimen	Rifamycin containing regimen

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	up to 12 months	Incidence of treatment related any adverse event

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measure	up to 12 months	proportion of treatment interruption

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan