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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

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

Treatment groups

400 Participants
are divided into 4 treatment groups