Testing a treatment called isoniazid monotherapy to prevent the progression of chronic kidney disease in latent (without any symptoms) tuberculosis in Bangladesh

Phase 4

• Conditions: Chronic kidney disease with latent tuberculosis infection; Urological and Genital Diseases

• Registration Number: ISRCTN11515835
• Lead Sponsor: Kidney Foundation Hospital and Research Institute, Bangladesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-13
• Last Update Posted: 8 January 2024
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients (male or female) eGFR 20-60 [ml/min/1.73m²] attending Kidney Foundation Hospital, Bangladesh.
2. Aged 19 to 75 years inclusive
3. Willing to comply with study schedule
4. Interferon-gamma release assay (IGRA) positive

Exclusion Criteria

1. Active TB or previous known treatment of active TB or LTBI
2. Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease such as history of liver disease, including viral hepatitis, chronic liver disease, harmful alcohol intake.
3. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug
4. Subject with a known hypersensitivity or contraindication to Isoniazid and Pyridoxine
5. Female participant who is pregnant or lactating during the trial.
6. History of functional kidney transplant 6 months before study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of change in renal function assessed by eGFR [ml/min/1.73m²] over 2 years (1.5yrs after administration of 6 months of isoniazid therapy 5mg/kg (maximum 300mg) plus pyridoxine 20mg or no treatment.<br>The eGFR will be calculated using the CKD EPI equation using Age, sex, and creatinine. This will be evaluated every 3 months as part of standard care at 0, 3, 6, 9, 12, 15,18,21 and 24 months.<br>

Secondary Outcome Measures

Name	Time	Method
1. Reactivation of TB monthly during the 2 years follow up period from initiation of trial.<br>If positive: patient will be withdrawn from trial to initiate TB treatment as deemed clinically appropriate (but will continue follow up for endpoints).<br>2. Survival benefits-mortality measured using Kaplan-Meier estimate at the end of the study.<br>3. Effect on other parameters of kidney function performed at CKD clinic as standard practice including but exclusively: urinary microalbumin (ACR), 0, 3, 6 and 12 months.<br>4. The effect of IMP in the inflammatory status assessed by serum CRP and optical density of IGRA at screening then 9 months and 12 months from initiation of therapy<br>5. Safety endpoints: SAEs, AEs and liver enzymes (SGPT, ALP, Bilirubin) at 0, 3, 6 and 12 months