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

Study acronym: EMPASTONE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site contacts updated at 1 of 21 sitesv4
  2. Recruitment opened
    • Start date changed from estimate of Jun 2026 to Jul 2, 2026
    • Site details revised at 21 of 21 sites
    v3
  3. Primary completion date: Feb 2030 to Sep 2030v2 Show 7 more changesShow less
    • Start date: May 2025 to Jun 2026
    • Enrollment target: 380 to 400
    • Study completion date: Jun 2030 to Sep 2030
    • Interventions: Empagliflozin 25 MG (Drug), Generic dietary counseling (Behavioral), Personalized dietary counseling (Behavioral), Placebo (Drug) to Empagliflozin 10 MG (Drug), Generic dietary counseling (Behavioral), Personalized dietary counseling (Behavioral), Placebo (Drug)
    • Eligibility criteria expanded, about 97 words
    • Study description expanded, about 26 words
    • Study sites revised (21)
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06653738
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Conditions
(from sponsor)		 Kidney Stone, Nephrolithiasis, Dietary Exposure
Related terms Kidney Calculi, Nephrolithiasis
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov