Isoniazid Toxicity, Kidney Transplantation, Tuberculosis
Conditions
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.
Interventions
DRUGIsoniazid
Those with risk factors were recommended a 6-month prophylaxis regimen, consisting of INH (300 mg/d) and pyridoxine (10 mg/d to prevent INH-related neurotoxicity).
Sponsors
West China Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. living-donor kidney transplant recipients 2. receiving standard triad immunosuppressive regimen
Exclusion criteria
1. active TB infection 2. multiorgan transplantation 3. liver cirrhosis 4. malignancy history in the donor and recipient 5. human immunodeficiency virus infection 6. those who had received a nine-month course of INH.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of post-transplant active TB | from transplant to post-transplant for up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of side effects of INH | Within 6 months of INH regimen |
Countries
China
Outcome results
None listed