| 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
|
|
|
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
|
|
|
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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