Home » Trials » SLCTR/2023/012

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


SLCTR Registration Number


Date of Registration

22 May 2023

The date of last modification

May 22, 2023

Application Summary

Scientific Title of Trial

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

Public Title of Trial

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

Disease or Health Condition(s) Studied


Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

ERC/2022/46, Ethics Review Committee, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka

Trial Details

What is the research question being addressed?

What is the impact of empagliflozin on nephrolithiasis compared to placebo, among patient without diabetes in reducing the number and/or size of renal stones

Type of study


Study design


Randomized controlled trial


Double blinded : Participants, Investigators







Study Phase

Phase 3

Intervention(s) planned

• 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 the kidney as stratification factor (50% of patients with renal cortical stones and 50% with renal medullary stones. Randomization code will be prepared by using online program such as sealed envelope. The allocation ratio of treatment and control groups will be 1:1. Sixty participants will be randomized in equal proportions to two groups (30 participants per group), one group receiving 10 mg empagliflozin and the other group will be receiving placebo.

Study duration will be 28 days. Treatment allocation will be done according to the above randomization list. There will be no matching on age and sex.

The eligible study subjects will be explained about the study objectives and consent will be obtained. The study subjects will be selected from the first diagnosed non-diabetic patient who fulfils inclusion criteria. A total of 60 participants will be sequentially recruited to the study.

• Test drug – Empagliflozin, !0mg, once daily dose for four weeks. • Placebo composition – Starch, !0mg

Study group will be given empagliflozin 10 mg orally for 28 days and placebo will be given to the control group for 28 days. The placebo composition will be starch 10 mg.

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

  • 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

Primary outcome(s)


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 outcome(s)


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.

  1. 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)


Target number/sample size

60 (30 in each group)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

Self funded

Regulatory approvals


State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka
Institutional Address:Secretary, ERC, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
Email: erc@med.rjt.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

RDWR Karunarathna
Senior registrar in general medicine
Professorial unit, teaching hospital, Anuradhapura


Contact Person for Public Queries

Prof Sisira Siribaddana
Professorial Unit, Teaching hospital, Anuradhapura
025-222 7706
Need phone number

Need email

Primary study sponsor/organization

Professorial Medical Unit

Teaching hospital Anuradhapura

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

version 4, 24.01.2023

Protocol URL

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results