Impact of empagliflozin on nephrolithiasis among patients without diabetes compared to a placebo in reduction in the number and/or size of renal stones

Impact of the SGLT2 inhibitor, empagliflozin on nephrolithiasis among non diabetes: a randomized, double-blind, placebo-controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2023/012

Enrollment

Unknown

Registered

2023-05-22

Start date

2023-05-23

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Nephrolithiasis

Interventions

• Study setting- medical wards and clinics, Teaching Hospital, Anuradhpura • Randomisaton method- We will use stratified randomization to assign patients to different trial arms with stone location in

Eligibility

Inclusion criteria

Inclusion criteria: • Both male and female • Minimum age- 18 yrs • Maximum age- 75 yrs. • Having renal parenchymal and pelvicalyceal stones • With kidney stone with the size of more than four millimeters on abdominal CT scan

Exclusion criteria

Exclusion criteria: * Size less than four millimetre stones in the kidney * Having ureteric stones * Having known allergy to study drug * eGFR less than 30 m2, * Pregnant women * Lactating women * Kidney transplant patients

Design outcomes

Primary

Measure	Time frame
Presence of the kidney stones and its mean size will be measured (The total volume of stones) before and after four weeks of treatment with study drugs/placebo. Repeat CT abdomen (low dose protocol) will be done in four weeks (28-30 days) to reassess the size of the stone. The mean size difference of the kidney stones will be compared in two groups before and following the intervention. [Before and after four weeks of starting treatment]	—

Measure

Time frame

Presence of the kidney stones and its mean size will be measured (The total volume of stones) before and after four weeks of treatment with study drugs/placebo. Repeat CT abdomen (low dose protocol) will be done in four weeks (28-30 days) to reassess the size of the stone. The mean size difference of the kidney stones will be compared in two groups before and following the intervention. [Before and after four weeks of starting treatment]

—

Secondary

Measure	Time frame
Number of episodes of pain measured by visual analogue scale (1-10). New onset of colicky pain may reflect passage of parenchymal and pelvicalyceal stone through the ureter, thereby it may reflect reduction in size of the stone. This will be measured in 7 days and 28 days when we meet the patient physically. [This will be measured in 7 days and 28 days when we meet the patient physically. ] 2. Reduction in the number of stones This study will only recruit renal parenchymal and pelvicalyceal stones. [The number of stones will be measured at the start and end of four weeks (28-30 days)]	—

Measure

Time frame

Number of episodes of pain measured by visual analogue scale (1-10). New onset of colicky pain may reflect passage of parenchymal and pelvicalyceal stone through the ureter, thereby it may reflect reduction in size of the stone. This will be measured in 7 days and 28 days when we meet the patient physically. [This will be measured in 7 days and 28 days when we meet the patient physically. ] 2. Reduction in the number of stones This study will only recruit renal parenchymal and pelvicalyceal stones. [The number of stones will be measured at the start and end of four weeks (28-30 days)]

—

Countries

Sri Lanka

Contacts

Public ContactRDWR Karunarathna

Senior registrar in general medicine

wasantharuwan67@gmail.com0717077500

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026