Clinical Trial

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

Study acronym: EMPASTONE
Recruiting Phase 3
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-08
Trial Details
NCT Number NCT06653738
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Conditions Kidney Stone, Nephrolithiasis, Dietary Exposure
Enrollment 400 participants
Start Date 2026-07-02
Primary Completion 2030-09 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-03