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Clinical Trials/CTRI/2024/04/066291
CTRI/2024/04/066291
Not yet recruiting
Not Applicable

A prospective study on Dapagliflozin usage rate among CKD patients; insights from a tertiary clinic.

Aisha Rania1 site in 1 country189 target enrollmentStarted: May 6, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Aisha Rania
Enrollment
189
Locations
1
Primary Endpoint
The study results will give an overview of the use of dapagliflozin in CKD patients, Identification of barriers

Overview

Brief Summary

Chronic kidney disease (CKD) is a condition that leads to a gradual decline in kidney function. It’s a major global health concern. Dapagliflozin is a Sodium-glucose co-transporter 2 inhibitor (SGLT2i) known for reducing glycated hemoglobin (HbA1c). The results from the Dapagliflozin-Chronic Kidney Disease (DAPA-CKD) trial affirm that the positive impacts of SGLT2 inhibitors on kidneys are not solely tied to glucose reduction. As a result, this drug class is now deemed fundamental therapy for CKD. The utilisation of SGLT2 inhibitors has been limited, and those at the highest risk are less likely to be prescribed them. The reasons for the underuse of SGLT2 inhibitors in routine practice are complex and not fully understood. Medication knowledge can be defined as the awareness of the drug name, purpose, administration schedule, adverse effects or side effects, and special administration instructions. Providing patients with informative leaflets can enhance their comprehension and awareness of chronic kidney disease. Adverse Drug Reaction (ADR) is characterized as an unintended and noxious response to a drug, occurring at doses typically used in humans for prophylaxis, diagnosis, treatment of a disease, or the modification of physiological function. Our study is conducted in a tertiary care clinic aims to assess the usage rate of dapagliflozin and factors affecting its usage among patients with CKD, assess the basic medication knowledge of CKD patients and see the importance of developing and evaluating a patient information leaflet (PIL) for CKD patients. Identifying and reporting any Adverse Drug Reactions (ADR) that occur after taking Dapagliflozin medication. Data collection involves data collection forms and questionnaires and interviewing the doctor. The collected data will be analysed using descriptive statistical tools (MS Excel, SPSS) such as frequency, percentage, mean, standard deviation, chi-square test, and independent t-test. The study will utilize the WHO UMC Causality Assessment Scale to evaluate and assess adverse drug reactions (ADRs) in our research. The study’s implications are significant, providing insights into rate of utilisation of dapagliflozin amongst CKD patients, the importance of evaluating and developing a PIL for CKD patients, and identifying and reporting ADRs. Disseminating these findings to prescribers and clinicians will improve rational drug therapy and improve treatment outcomes in CKD patients.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient diagnosed with CKD.

Exclusion Criteria

  • Those with the advanced malignancy,Patients undergoing hemodialysis,Those who are diagnosed with psychiatric illness.Pregnant and lactating women.Patients with deafness or visual impairment.

Outcomes

Primary Outcomes

The study results will give an overview of the use of dapagliflozin in CKD patients, Identification of barriers

Time Frame: at base line, 4weeks, 8 weeks

hindering their prescription

Time Frame: at base line, 4weeks, 8 weeks

Secondary Outcomes

  • Level of the medication knowledge among the patients undergoing treatment(which helps in managing the health issues in these patients & as well as improve the treatment outcome.)

Investigators

Sponsor
Aisha Rania
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Aisha Rania

Karavali College of Pharmacy

Study Sites (1)

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