Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients

Sichuan University

Status: Completed

Conditions: Isoniazid Toxicity; Tuberculosis; Kidney Transplantation

Treatments: Drug: Isoniazid

Study type: Interventional

Funder types: Other

Identifiers

NCT06512831

WestChina-INH-KT

Details and patient eligibility

About

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.

Enrollment: 1,348 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,348 participants in 3 patient groups

TB Risk factors with INH group (R-INH)

Experimental group

Treatment:

Drug: Isoniazid

TB Risk factors without INH group (R-NINH)

No Intervention group

Non-Risk group (NR)

No Intervention group