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NOT YET RECRUITING
NCT06653738
PHASE3

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

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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 25 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2025-05

Completion Date

2030-06

Last Updated

2024-10-22

Healthy Volunteers

No

Interventions

DRUG

Empagliflozin 25 MG

Once daily per os for 3 years

DRUG

Placebo

Once daily per os for 3 years

BEHAVIORAL

Personalized dietary counseling

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

BEHAVIORAL

Generic 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

Charité University Medicine Berlin

Berlin, Germany

Verona University Hospital

Verona, Italy

Kantonsspital Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

University Hospital Basel

Basel, Switzerland

Regionalspital Bellinzona e Valli

Bellinzona, 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

Kantonsspital Solothurn

Solothurn, Switzerland

Universitätsspital Zürich

Zurich, Switzerland