Comparison of Pharmacokinetic Principles of Medications for Tuberculosis (TB) with and without Chronic Kidney Disease (CKD).
- Conditions
- Health Condition 1: N18- Chronic kidney disease (CKD)Health Condition 2: A150- Tuberculosis of lung
- Registration Number
- CTRI/2020/09/027951
- Lead Sponsor
- Indian Council of Medical Research Technically Approved Awaiting for further response
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1- Tuberculosis (TB) with Chronic Kidney Disease (CKD) group
a. Age group between 18 to 70
b. Patients with CKD having tuberculosis and received
treatment minimum for two weeks.
2- Tuberculosis (TB) without Chronic Kidney Disease (CKD) group
a.Age group between 18 to 70
b.Patients with tuberculosis received treatment minimum for two weeks.
3-Chronic kidney Disease patients with dialysis group
a.Age group between 18 to 70
b.Patients of CKD on maintenance of dialysis and
having tuberculosis received treatment minimum for two weeks.
a.Human immunodeficiency virus (HIV) infected subjects
b.Viral Hepatitis
c.Any Hepatic Disease Subjects
d.Renal transplantation subjects
b.Acute Kidney Injury Subjects
c.Non-adherence to medication: It is defined as If patients take less than 80% of their prescribed medication(s), they are considered nonadherent.
d.Pregnant women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcomes:- <br/ ><br> <br/ ><br> <br/ ><br>a)ATT related Side effects <br/ ><br> <br/ ><br>b)Population Pharmacokinetic model analysis of ATT drug <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 3 Years
- Secondary Outcome Measures
Name Time Method a) Identification of various attributable factors responsible for alteration of the drug level. <br/ ><br>Timepoint: 3 years