Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients: A Retrospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- West China Hospital
- Enrollment
- 1,348
- Locations
- 1
- Primary Endpoint
- The incidence of post-transplant active TB
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TB Risk factors with INH group (R-INH)
Intervention: Isoniazid (Drug)
Outcomes
Primary Outcomes
The incidence of post-transplant active TB
Time Frame: from transplant to post-transplant for up to 5 years
Secondary Outcomes
- The incidence of side effects of INH(Within 6 months of INH regimen)
Investigators
Tao Lin
Professor Tao Lin
West China Hospital