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Completed

NCT Number: NCT06512831

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

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.

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Key information

Conditions

Kidney Transplantation Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Isoniazid Toxicity Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isoniazid

Drug

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).

Primary outcomes

  1. The incidence of post-transplant active TB

    Time frame: from transplant to post-transplant for up to 5 years

Secondary outcomes

  1. The incidence of side effects of INH

    Time frame: Within 6 months of INH regimen

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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