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
Primary Purpose
Pulmonology
Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Rifamycin-containing regimen
Rifamycin-free regimen
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonology focused on measuring latent tuberculosis infection,mycobacterium tuberculosis
Eligibility Criteria
Inclusion Criteria:
- Received kidney transplant, and
- Will receive interferon-gamma release assay (IGRA) for LTBI, and
- If IGRA was positive, participants agree to receive LTBI treatment
Exclusion Criteria:
- Age < 20 years old
- pregnancy
- Suspicious active tuberculosis
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Rifamycin containing regimen
Rifamycin-free regimen
Arm Description
Rifamycin containing regimen
Rifamycin-free regimen
Outcomes
Primary Outcome Measures
Primary Outcome Measure
Incidence of treatment related any adverse event
Secondary Outcome Measures
Secondary Outcome Measure
proportion of treatment interruption
Full Information
NCT ID
NCT05588492
First Posted
May 3, 2022
Last Updated
October 18, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05588492
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonology
Keywords
latent tuberculosis infection,mycobacterium tuberculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rifamycin containing regimen
Arm Type
Experimental
Arm Description
Rifamycin containing regimen
Arm Title
Rifamycin-free regimen
Arm Type
Experimental
Arm Description
Rifamycin-free regimen
Intervention Type
Drug
Intervention Name(s)
Rifamycin-containing regimen
Intervention Description
Rifamycin-containing regimen
Intervention Type
Drug
Intervention Name(s)
Rifamycin-free regimen
Intervention Description
Rifamycin-free regimen
Primary Outcome Measure Information:
Title
Primary Outcome Measure
Description
Incidence of treatment related any adverse event
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Secondary Outcome Measure
Description
proportion of treatment interruption
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Received kidney transplant, and
Will receive interferon-gamma release assay (IGRA) for LTBI, and
If IGRA was positive, participants agree to receive LTBI treatment
Exclusion Criteria:
Age < 20 years old
pregnancy
Suspicious active tuberculosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chin-Chung Shu
Phone
+886-2312-3456
Ext
53087
Email
ccshu@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Chung Shu
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Chung Shu
Phone
+886223123456
12. IPD Sharing Statement
Learn more about this trial
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
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