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Clinical Trials/NCT06512831
NCT06512831CompletedNot Applicable

Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients: A Retrospective Cohort Study

West China Hospital1 site in 1 country1,348 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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)

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tao Lin

Professor Tao Lin

West China Hospital

Study Sites (1)

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