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Comparison of Pharmacokinetic Principles of Medications for Tuberculosis (TB) with and without Chronic Kidney Disease (CKD).

Comparison of Pharmacokinetic Principles of Anti-tubercular Drugs in Tuberculosis (TB) with and without Chronic Kidney Disease (CKD).

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/09/027951
Enrollment
230
Registered
2020-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N18- Chronic kidney disease (CKD) Health Condition 2: A150- Tuberculosis of lung

Interventions

None listed

Sponsors

Indian Council of Medical Research Technically Approved Awaiting for further response
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Primary Outcomes:- a)ATT related Side effects b)Population Pharmacokinetic model analysis of ATT drug Timepoint: 3 Years

Secondary

MeasureTime frame
a) Identification of various attributable factors responsible for alteration of the drug level. Timepoint: 3 years

Countries

India

Contacts

Public ContactDr Ravindra Prabhu A

Kasturba Medical College Manipal,Manipal Academy of Higher Education, Manipal

ravindra.prabhu@manipal.edu9448107771

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 2, 2026