Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients
Not Applicable
Completed
- Conditions
- Kidney TransplantationIsoniazid ToxicityTuberculosis
- Interventions
- Registration Number
- NCT06512831
- Lead Sponsor
- West China Hospital
- Brief Summary
Tuberculosis (TB) is a major and severe opportunistic infection among solid organ transplant recipients. Chemoprophylaxis is advised for those with latent tuberculosis infection (LTBI). However, the effectiveness of an isoniazid (INH) prophylactic approach based on TB risk factors, without relying on tuberculin skin test (TST) or interferon-gamma release assay (IGRA), remains uncertain. Therefore, the investigators conducted this retrospective study to evaluate the safety and efficacy of a 6-month INH prophylaxis regimen guided by TB risk factors in kidney transplant recipients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1348
Inclusion Criteria
- living-donor kidney transplant recipients
- receiving standard triad immunosuppressive regimen
Exclusion Criteria
- active TB infection
- multiorgan transplantation
- liver cirrhosis
- malignancy history in the donor and recipient
- human immunodeficiency virus infection
- those who had received a nine-month course of INH.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TB Risk factors with INH group (R-INH) Isoniazid -
- Primary Outcome Measures
Name Time Method The incidence of post-transplant active TB from transplant to post-transplant for up to 5 years
- Secondary Outcome Measures
Name Time Method The incidence of side effects of INH Within 6 months of INH regimen
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China