Home » Trials » SLCTR/2023/012
Impact of the SGLT2 inhibitor, empagliflozin on nephrolithiasis among non diabetes: a randomized, double-blind, placebo-controlled trial.
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SLCTR Registration Number
SLCTR/2023/012
Date of Registration
The date of last modification
May 22, 2023
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
Nephrolithiasis
Scientific Acronym
EMPACAL trial
Public Acronym
EMPACAL trial
Brief title
None
Universal Trial Number
U1111-1285-1126
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
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
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators
Control
Placebo
Assignment
Parallel
Purpose
Treatment
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
Primary outcome(s)
|
1.
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)
|
1.
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.
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
2023-05-23
Anticipated end date
2023-09-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
Pending
Status
Approved
Date of Approval
2023-03-07
Approval number
ERC/2022/46
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 |
| Telephone: | +94252053633 |
| Email: | erc@med.rjt.ac.lk |
Contact person for Scientific Queries/Principal Investigator
RDWR Karunarathna
Senior registrar in general medicine
Professorial unit, teaching hospital, Anuradhapura
0717077500
0706577500
wasantharuwan67@gmail.com
Contact Person for Public Queries
Prof Sisira Siribaddana
Professor
Professorial Unit, Teaching hospital, Anuradhapura
025-222 7706
Need phone number
Need email
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
version 4, 24.01.2023
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
