A single centre, open-label, randomised clinical trial evaluating Isoniazid Monotherapy treatment to Prevent Accelerated Chronic kidney disease in latent Tuberculosis in a High Incidence Country.
Chronic kidney disease with latent tuberculosis infection
Intervention - IMP with 6 months isoniazid 5mg/kg/day maximum daily dose 300 mg (plus pyridoxine 20 mg) Comparison group – The alternative group will receive no treatment compared with the intervention group as per current practice in Bangladesh. Patients will then be randomized into one of two groups. One group will receive IMP daily, for 6 months while the second group will receive standard care (no specific treatment for LTBI) for 6 months. The randomization envelopes will be grouped into 20 Blocks (10 envelopes within each group). Each group will contain 5 envelopes specifying IMP and 5 no treatment in random order. Each envelope will be identified by the Block number and kit number The study will comprise of four stratified groups of patients: A. Diabetic and No Glomerulonephritis B. Diabetic and Glomerulonephritis C. Non-Diabetic and Glomerulonephritis D. Non-Diabetic and No Glomerulonephritis
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
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