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.
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.
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)
Factorial
Empagliflozin 10 MG
DrugOnce daily per os for 3 years
Placebo
DrugOnce daily per os for 3 years
Personalized dietary counseling
BehavioralPersonalized dietary counseling based on repeat 24-hr urine collections and dietary assessments for 3 years
Generic dietary counseling
BehavioralGeneric dietary counseling based on current guidelines without 24-hr urine collection results and without specific dietary assessments for 3 years
Number of patients with radiologic stone recurrence
Radiological stone recurrence is defined as a new stone formed or enlargement of a preexisting stone (assessed by low-dose CT of the kidney at the end of the study compared to the low-dose CT of the kidney at the baseline visit).
Time to symptomatic kidney stone recurrence up to 3 years (time-to-event)
Symptomatic recurrence is defined as the visible passage of a stone with or without accompanying typical symptoms (such as flank or loin pain and hematuria) or as the presence of a symptomatic or asymptomatic stone that was determined to require surgical removal.
Number of symptomatic stone recurrences per patient (cumulative)
Symptomatic recurrence is defined as the visible passage of a stone with or without accompanying typical symptoms (such as flank or loin pain and hematuria) or as the presence of a symptomatic or asymptomatic stone that was determined to require surgical removal.
Changes in blood parameters
Blood parameters will be measured at screening, Month 3, Year 1, Year 2 and Year 3.
Changes in urine parameters
24-hr urine analyses will be done at screening, Month 3, Year 1, Year 2 and Year 3. Note: results of 24-hr urine analyses will be blinded until the end of the study in patients randomized to generic dietary counselling.
Changes in blood pressure
Blood pressure measurements will be done at screening, Month 3, Year 1, Year 2 and Year 3.
Changes in weight
Weight, will be measured at screening, Month 3, Year 1, Year 2 and Year 3.
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