NCT05588492 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
| NCT ID | NCT05588492 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Taiwan University Hospital |
| Condition | Pulmonology |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2022-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Chin-Chung Shu
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT05588492 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Pulmonology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05588492 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05588492 currently recruiting?
Yes, NCT05588492 is actively recruiting participants. Contact the research team at ccshu@ntu.edu.tw for enrollment information.
Where is the NCT05588492 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05588492 clinical trial?
NCT05588492 is sponsored by National Taiwan University Hospital. The principal investigator is Chin-Chung Shu at National Taiwan University Hospital. The trial plans to enroll 500 participants.