Evaluating rifamycin regimens for preventing tuberculosis in kidney transplant patients
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
PHASE4 · National Taiwan University Hospital · NCT05588492
This study is testing if a new treatment with rifamycin can safely help kidney transplant patients who have latent tuberculosis infection avoid getting sick.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05588492 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of rifamycin-containing regimens for treating latent tuberculosis infection (LTBI) in kidney transplant recipients (KTRs). Given the high risk of tuberculosis reactivation in this population, the study aims to assess the completion rates and potential drug-drug interactions with immunosuppressants. Participants who test positive for LTBI will be monitored for adverse events and the overall prevention effect of the treatment. The trial seeks to provide clarity on the best LTBI treatment options for KTRs, a group that has not been extensively studied in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 and older who have received a kidney transplant and have tested positive for latent tuberculosis infection.
Not a fit: Patients under 20 years old, pregnant individuals, or those with suspected active tuberculosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective LTBI treatment option for kidney transplant recipients, reducing their risk of tuberculosis reactivation.
How similar studies have performed: While there have been studies on LTBI treatment in general populations, this specific approach for kidney transplant recipients is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Chin-Chung Shu — National Taiwan University Hospital
- Study coordinator: Chin-Chung Shu
- Email: ccshu@ntu.edu.tw
- Phone: +886-2312-3456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonology, latent tuberculosis infection,mycobacterium tuberculosis