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

Pulmonology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588492
• Other study ID #: 202110073MIND
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2022
• Source: National Taiwan University Hospital
• Contact: Chin-Chung Shu
• Phone: +886-2312-3456
• Email: ccshu[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Latent Tuberculosis
• Pulmonology
• Tuberculosis

Intervention

Drug:
• Rifamycin-containing regimen
Rifamycin-containing regimen
• Rifamycin-free regimen
Rifamycin-free regimen

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure	Incidence of treatment related any adverse event	up to 12 months
Secondary	Secondary Outcome Measure	proportion of treatment interruption	up to 12 months