About this trial
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.
Eligibility criteria
Qualifiers
Written, informed consent.
Age 18 years or older.
Recurrent kidney stone disease with 2 or more stone episodes in the last 10 years prior to randomization.
Last kidney stone containing 50% or more of CaOx, CaP or a mixture of both.
Disqualifiers
Known history of secondary or Mendelian causes of calcium nephrolithiasis
Type I diabetes mellitus
History of ketoacidosis
Chronic Kidney Disease (CKD) stage 4 or 5 (defined as CKD-EPI eGFR <30 mL/min)
Trial design
Treatments tested in this trial
- Empagliflozin 10 MG
- Placebo
- Personalized dietary counseling
- Generic dietary counseling