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CTRI Number  CTRI/2024/04/066291 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective , non interventional 
Study Design  Other 
Public Title of Study   Rate of usage of drug dapagliflozin in Chronic kidney disease patients in clinic. 
Scientific Title of Study   A prospective study on Dapagliflozin usage rate among CKD patients; insights from a tertiary clinic. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aisha Rania 
Designation  Student 
Affiliation  Karavali College of Pharmacy 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  7019368657  
Fax    
Email  raniaaisha3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Thanveer Ahammed Chonari 
Designation  Assistant professer 
Affiliation  Karavali College Of Pharmacy 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  8921269228  
Fax    
Email  thanveerahammed24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Thanveer Ahammed Chonar 
Designation  Assistant professer 
Affiliation  Karavali College Of Pharmacy 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028

Dakshina Kannada
KARNATAKA
575028
India 
Phone  8921269228  
Fax    
Email  thanveerahammed24@gmail.com  
 
Source of Monetary or Material Support  
Father Muller Medical College Hospital,Mangalore,Karnataka-575028 
 
Primary Sponsor  
Name  Aisha Rania 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka-575028  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aisha Rania  Father Muller Medical College Hospital  Department of Nephrology,Father Muller Medical College Hospital,Kankanady,Mangalore-575002
Dakshina Kannada
KARNATAKA 
7019368657

raniaaisha3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patient diagnosed with CKD 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study results will give an overview of the use of dapagliflozin in CKD patients, Identification of barriers
hindering their prescription 
at base line, 4weeks, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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.
Identification & reporting adverse drug reactions will be useful in providing better treatment & thus
enable rationalization of drug therapy.
 
at base line, 4 weeks, 8 weeks 
 
Target Sample Size   Total Sample Size="189"
Sample Size from India="189" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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