search
Back to results

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
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonology focused on measuring latent tuberculosis infection,mycobacterium tuberculosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
May 3, 2022
Last Updated
October 18, 2022
Sponsor
National Taiwan University Hospital
search

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

We'll reach out to this number within 24 hrs