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Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Sponsor: Insel Gruppe AG, University Hospital Bern
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
Empagliflozin 25 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
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