Ireland
--:--IST
Recruiting Phase 3

Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention

NCT06653738 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2026-07-02
Last updated
2026-08-03

Condition(s) studied

Kidney StoneNephrolithiasisDietary Exposure

Investigational drug(s) / intervention(s)

Empagliflozin 10 MG →PlaceboPersonalized dietary counselingGeneric dietary counseling

Empagliflozin 10 MG: Once daily per os for 3 years

Placebo: Once daily per os for 3 years

Personalized dietary counseling: Personalized dietary counseling based on repeat 24-hr urine collections and dietary assessments for 3 years

Generic dietary counseling: Generic dietary counseling based on current guidelines without 24-hr urine collection results and without specific dietary assessments for 3 years

Study summary

The aim of this randomized trial with a 2-by-2 factorial design is to test the efficacy of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones.

Study interventions:

* Empagliflozin 10 mg once daily per os for 36 months
* Personalized dietary counseling for 36 months.

Control interventions:

* Placebo once daily per os for 36 months
* Generic dietary counseling for 36 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: 1. Written, informed consent. 2. Age 18 years or older. 3. Recurrent kidney stone disease with 2 or more stone episodes in the last 10 years prior to randomization. 4. Last kidney stone containing 50% or more of CaOx, CaP or a mixture of both. 5. If taking guideline-recommended medications for kidney stone prophylaxis (e.g. citrate salts), patients must have been on a stable regimen for at least 60 days before randomization and willing to remain on this stable regimen for the duration of the study. Exclusion criteria: 1. Known history of secondary or Mendelian causes of calcium nephrolithiasis 2. Type I diabetes mellitus 3. History of ketoacidosis 4. Chronic Kidney Disease (CKD) stage 4 or 5 (defined as CKD-EPI eGFR \<30 mL/min) 5. Kidney transplant recipient 6. History of recurrent urinary tract infections, defined as \>3 episodes within the year prior to randomization 7. Heart failure. Symptomatic patients with suspected heart failure must be evaluated before study enrollment 8. Treatment with an SGLT2i within 4 weeks prior to randomization. 9. Active cancer treatment 10. Pregnancy and/or breastfeeding. Women of childbearing potential (i.e., premenopausal women who have not undergone surgical sterilization and are sexually active with a male partner) must have a negative urine or blood pregnancy test prior to enrollment 11. Known allergy to the study drug 12. Inability to understand and follow the study procedures 13. Vulnerable individual, e.g. individual incapable of judgement or currently incarcerated or otherwise institutionalized (priosner), or refugee 14. Concomitant participation in another interventional clinical trial within 4 weeks prior to randomization and during the current trial 15. Prior enrollment in the EMPASTONE trial

Primary outcome measure(s)

  • Number of patients with radiologic stone recurrence — After 3 years
    Radiological stone recurrence is defined as a new stone formed or enlargement of a preexisting stone (assessed by low-dose CT of the kidney at the end of the study compared to the low-dose CT of the kidney at the baseline visit).

Trial sites (21)

FacilityCityRegionStatus
University Hospital Amiens-Picardie Amiens France Not Yet Recruiting
Hôpital Tenon Paris France Not Yet Recruiting
Hôpital Européen Georges Pompidou Paris France Not Yet Recruiting
Charité University Medicine Berlin Berlin Germany Not Yet Recruiting
Università della Campania "Luigi Vanvitelli" Naples Italy Not Yet Recruiting
Verona University Hospital Verona Italy Not Yet Recruiting
Kantonsspital Aarau Aarau Switzerland Not Yet Recruiting
Kantonsspital Baden Baden Switzerland Not Yet Recruiting
University Hospital Basel Basel Switzerland Not Yet Recruiting
Inselspital Bern Bern Switzerland Recruiting
Kantonsspital Chur Chur Switzerland Not Yet Recruiting
Kantonsspital Fribourg Fribourg Switzerland Not Yet Recruiting
University Hospital Geneva (HUG) Geneva Switzerland Not Yet Recruiting
Lausanne University Hospital (CHUV) Lausanne Switzerland Not Yet Recruiting
Kantonsspital Luzern Lucerne Switzerland Not Yet Recruiting
Regionalspital Lugano Lugano Switzerland Not Yet Recruiting
Kantonsspital Neuchâtel Neuchâtel Switzerland Not Yet Recruiting
Kantonsspital Olten Olten Switzerland Not Yet Recruiting
Kantonsspital St. Gallen Sankt Gallen Switzerland Not Yet Recruiting
Kantonsspital Sion Sion Switzerland Not Yet Recruiting
Universitätsspital Zürich Zurich Switzerland Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06653738 on ClinicalTrials.gov ↗ ← All trials in Germany