| CTRI Number |
CTRI/2025/02/081391 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Role of Dapagliflozin in Chronic Kidney Disease Progression |
|
Scientific Title of Study
|
Efficacy of dapagliflozin in spectrum of chronic kidney disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Twinkle Pawar |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Nephrology,
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
7719920761 |
| Fax |
|
| Email |
pawartwinkle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Twinkle Pawar |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Nephrology,
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
7719920761 |
| Fax |
|
| Email |
pawartwinkle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manish Balwani |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Nephrology,
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
7719920761 |
| Fax |
|
| Email |
balwani.manish@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Medical Sciences Sawangi (Meghe), Wardha, Maharashtra, India- 442001 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NIL |
| Type of Sponsor |
Other [ Nil] |
|
|
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 |
| Twinkle Pawar |
Acharya Vinoba Bhave Rural Hospital |
Sawangi
(Meghe) Wardha
Wardha
MAHARASHTRA |
7719920761
pawartwinkle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N18||Chronic kidney disease (CKD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DAPAGLIFLOZIN |
eGFR 25ml/min/1.73m2 to be given DAPAGLIFLOZIN |
| Comparator Agent |
SERUM CREATININE AND UPCR |
BASELINE SERUM CREATININE AND UPCR AND COMPARISON AFTER 6 MONTHS OF STARTING DRUG |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with type 1 diabetes mellitus., Patients with polycystic kidney disease., Patient with active urinary tract infection. |
|
| ExclusionCriteria |
| Details |
Patients with type 1 diabetes mellitus., Patients with polycystic kidney disease, Patient with active urinary tract infection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the trend of eGFR / serum creatinine and proteinuria over a period of six months after starting dapagliflozin |
All parameters will be assessed at the baseline
at the time of enrollment at day 1 and 24 weeks after starting dapagliflozin |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for incidence of urinary tract infection, limb amputation, hypoglycemia in period of six months after starting medication |
All parameters will be assessed at the baseline
at the time of enrollment at day 1 & 24 weeks after starting dapagliflozin |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
15/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A study conducted in a rural tertiary care hospital in Central India aiming to investigate Efficacy of dapagliflozinin spectrum of chronic kidney disease
. The rationale behind the study is to assess the trend of eGFR / serum creatinine and proteinuria over a period of six months after starting dapagliflozin& to look for Side effects in period of six months after starting medication and potentially improving patient outcomes. The study design is a cross-sectional study with a duration of 24 months, conducted at Acharya Vinoba Bhave Rural Hospital. The sample size is determined to be 112 patients meeting specific inclusion criteria. Data collection involves obtaining baseline demographic and clinical data, including age, gender, BMI, and blood pressure, and analyzing serum samples for various biochemical markers. Ethical considerations, including patient confidentiality and informed consent, are emphasized. The primary outcome is the to assess the trend of eGFR / serum creatinine and proteinuria over a period of six months after starting dapagliflozin. The abstract highlights the study’s potential contributions to CKD management in the rural Indian population. |