Chronic kidney disease with latent tuberculosis infection Urological and Genital Diseases
Conditions
Interventions
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 interventi
Sponsors
Kidney Foundation Hospital and Research Institute, Bangladesh
Bart's Health NHS Trust
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in renal function assessed by eGFR [ml/min/1.73m²] over 2 years (1.5 years after administration of 6 months of isoniazid therapy 5mg/kg (maximum 300mg) plus pyridoxine 20mg or no treatment. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reactivation of TB monthly during the 2 years follow-up period from initiation of trial. If positive: patient will be withdrawn from trial to initiate TB treatment as deemed clinically appropriate (but will continue follow up for endpoints). 2. Survival benefits-mortality measured using Kaplan-Meier estimate at the end of the study. 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. 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 5. Safety endpoints: SAEs, AEs and liver enzymes (SGPT, ALP, Bilirubin) at 0, 3, 6 and 12 months | — |
Countries
Bangladesh
Contacts
Public ContactTasnuva Sarah Kashem
Outcome results
None listed