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CTRI Number  CTRI/2025/12/098403 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of Dapagliflozin versus placebo in preventing kidney stone recurrence 
Scientific Title of Study   Effect of Dapagliflozin versus standard care on risk of recurrence of kidney stones measured by urinary super-saturation: A Randomised placebo controlled study 
Trial Acronym  DAPASTONE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vipin Chandra 
Designation  Associate Professor 
Affiliation  All india institute of Medical sciences, patna 
Address  Department of Urology AIIMS PATNA, Near Valmi PIN-801507
VIPIN CHANDRA Associate Professor Department of Urology AIIMS PATNA, Near Valmi PIN-801507
Patna
BIHAR
801507
India 
Phone  08442840839  
Fax    
Email  ccchandra2001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vipin Chandra 
Designation  Associate Professor 
Affiliation  All india institute of Medical sciences, patna 
Address  Department of Urology AIIMS PATNA, Near Valmi PIN-801507
VIPIN CHANDRA Associate Professor Department of Urology AIIMS PATNA, Near Valmi PIN-801507
Patna
BIHAR
801507
India 
Phone  08442840839  
Fax    
Email  ccchandra2001@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vipin Chandra 
Designation  Associate Professor 
Affiliation  All india institute of Medical sciences, patna 
Address  Department of Urology AIIMS PATNA, Near Valmi PIN-801507
VIPIN CHANDRA Associate Professor Department of Urology AIIMS PATNA, Near Valmi PIN-801507
Patna
BIHAR
801507
India 
Phone  08442840839  
Fax    
Email  ccchandra2001@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, NEW DELHI V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari nagar, New Delhi, PIN Code- 110029 
Type of Sponsor  Government funding agency 
 
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 
DR VIPIN CHANDRA  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA  Department of Urology AIIMS PATNA, Near Valmi PIN-801507
Patna
BIHAR 		 8442840839

ccchandra2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ADVISORY COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N209||Urinary calculus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dapagliflozin 10 mg   dose of Dapagliflozin: 10 MG frequency: Once daily route of administration: oral total duration: 6 months  
Comparator Agent  Placebo  dose of placebo: empty tablet frequency: Once daily route of administration: oral total duration: 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria: Patients with known renal stone disease, after getting stone clearance by either medical expulsive therapy or by endoscopic surgery, Age between 18 to 60 years, Renal stones of the following types: Calcium phosphate, Calcium Oxalate, Uric acid.  
 
ExclusionCriteria 
Details  Exclusion criteria: Recurrent stone formers with confirmed alternate diagnoses such as incomplete RTA, Bartter’s, cystinuria, history of surgery in prior 6 weeks, Dehydration, Hemodynamic instability, Critical illness, Lower urinary tract symptoms, Severe renal failure with eGFR less than 45 ml per min, Patient on any SGLT2 inhibitors at the time of enrolment or in previous 3 months, Patient on teriparatide, bisphosphonates, denosumab at the time of enrolment or in previous 6 months, Sepsis or septic shock, Moribund patients with reduced life expectancy, Severe cardiopulmonary disease, Pregnancy and lactation, History of genital infections or urinary tract infections, Primary Hyperparathyroidism, Malignancy, Congenital anomaly of kidney and urinary tract  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in urinary super saturation in the study groups, urinary markers of inflammation and incidence of new stone formation  Baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="111"
Sample Size from India="111" 
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)   01/01/2026 
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="3"
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   Nephrolithiasis is a common renal disease that frequently recurs and amounts to large disease burden in Indian patients with no effective evidence based preventive medication. A huge number of patients have to undergo different types of surgeries for stone clearance. Despite of getting cleared stone almost 50 percent patients land up with re-stone formation in next 10 years. Patients with multiple stones and / or abnormal urinary super-saturation have high risk of repeated stone formation. Surgical interventions are associated with morbidity, prolonged hospital stay, sepsis or death in few cases. If not managed timely may lead to renal failure. There is no definitive means to prevent or delay the recurrence of stone disease in urinary tract. Sodium-glucose cotransporter-2 (SGLT2, encoded by SLC5A2) inhibitors, a novel class of antidiabetic agents, induce urinary glucose excretion by inhibiting SGLT2 at the S1 and S2 segments of the proximal tubules. Apart from glycaemic control, SGLT2 inhibitors have diverse functions, including blood pressure reduction improved cardiovascular outcomes, renoprotection, lipid improvement, and weight, visceral fat, and serum uric acid level reduction. 
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