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Role of Dapagliflozin versus placebo in preventing kidney stone recurrence

Effect of Dapagliflozin versus standard care on risk of recurrence of kidney stones measured by urinary super-saturation: A Randomised placebo controlled study - DAPASTONE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098403
Enrollment
111
Registered
2025-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N209- Urinary calculus, unspecified

Interventions

Intervention1: Dapagliflozin 10 mg: dose of Dapagliflozin: 10 MG frequency: Once daily route of administration: oral total duration: 6 months Control Intervention1: Placebo: dose of placebo: empty t

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Change in urinary super saturation in the study groups, urinary markers of inflammation and incidence of new stone formationTimepoint: Baseline and 6 months

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactVipin Chandra

All india institute of Medical sciences, patna

ccchandra2001@gmail.com08442840839

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026