Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Insel Gruppe AG, University Hospital Bern trials in Italy
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 Italy