RecruitingPhase 3NCT06653738

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

Randomized Placebo-controlled Trial to Assess Efficacies of EMPAgliflozin and Personalized Dietary Counselling for Kidney STONE Prevention in Patients With Calcium Kidney Stones Acronym: EMPASTONE Trial


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

400 participants

Start Date

Jul 2, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Empagliflozin 10 MG, a behavioral approach called Generic dietary counseling, and others for people with dietary exposure, kidney stone, and other related conditions. The study is currently recruiting participants at 21 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 10 MG

Once daily per os for 3 years

DRUGPlacebo

Once daily per os for 3 years

BEHAVIORALPersonalized dietary counseling

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

BEHAVIORALGeneric dietary counseling

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


Locations(21)

University Hospital Amiens-Picardie

Amiens, France

Hôpital Tenon

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Charité University Medicine Berlin

Berlin, Germany

Università della Campania "Luigi Vanvitelli"

Naples, Italy

Verona University Hospital

Verona, Italy

Kantonsspital Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

University Hospital Basel

Basel, Switzerland

Inselspital Bern

Bern, Switzerland

Kantonsspital Chur

Chur, Switzerland

Kantonsspital Fribourg

Fribourg, Switzerland

University Hospital Geneva (HUG)

Geneva, Switzerland

Lausanne University Hospital (CHUV)

Lausanne, Switzerland

Kantonsspital Luzern

Lucerne, Switzerland

Regionalspital Lugano

Lugano, Switzerland

Kantonsspital Neuchâtel

Neuchâtel, Switzerland

Kantonsspital Olten

Olten, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Kantonsspital Sion

Sion, Switzerland

Universitätsspital Zürich

Zurich, Switzerland

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NCT06653738


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