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

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT06653738
Phase
PHASE3
Status
Recruiting
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Conditions

  • Dietary Exposure
  • Kidney Stone
  • Nephrolithiasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Once daily per os for 3 years
  • Placebo — DRUG
    Once daily per os for 3 years
  • Personalized dietary counseling — BEHAVIORAL
    Personalized dietary counseling based on repeat 24-hr urine collections and dietary assessments for 3 years
  • Generic dietary counseling — BEHAVIORAL
    Generic dietary counseling based on current guidelines without 24-hr urine collection results and without specific dietary assessments for 3 years

Study Details

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.

Key Dates

First listed
Oct 22, 2024
Start date
Jul 2, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Empagliflozin and personalized dietary counseling
    Empagliflozin 10 mg once daily per os and personalized dietary counseling for 3 years
  • Placebo Comparator: Placebo and personalized dietary counseling
    Placebo once daily per os and personalized dietary counseling for 3 years
  • Experimental: Empagliflozin and generic dietary counseling
    Empagliflozin 10 mg once daily per os and generic dietary counseling for 3 years
  • Placebo Comparator: Placebo and generic dietary counseling
    Placebo once daily per os and generic dietary counseling for 3 years

Primary Outcome Measure

Number of patients with radiologic stone recurrence [ Time Frame: After 3 years ]

Central Contacts

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