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

NCT06512831 | Completed

• 1 other identifier: WestChina-INH-KT
• Study Type: interventional
• Target: 1,348
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Tuberculosis; Isoniazid Toxicity

Outcome Measures

Primary Outcomes (1)

• The incidence of post-transplant active TB

  from transplant to post-transplant for up to 5 years

Secondary Outcomes (1)

• The incidence of side effects of INH

  Within 6 months of INH regimen

Study Arms (3)

TB Risk factors with INH group (R-INH)

EXPERIMENTAL

Drug: Isoniazid

TB Risk factors without INH group (R-NINH)

NO INTERVENTION

Non-Risk group (NR)

NO INTERVENTION

Interventions

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).

TB Risk factors with INH group (R-INH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• living-donor kidney transplant recipients
• receiving standard triad immunosuppressive regimen

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Tao Lin

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 22, 2024
• Study Start: June 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)