Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STON… (NCT06653738) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
France, Germany, Italy380 participantsStarted 2025-05
Plain-language summary
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 25 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written, informed consent.
✓. Age 18 years or older.
✓. Recurrent kidney stone disease (2 or more stone episodes in the last 10 years).
✓. Last kidney stone containing 50% or more of CaOx, CaP or a mixture of both.
✓. If taking guideline-recommended medications for kidney stone prophylaxis (e.g. citrate salts) patients must have been on a stable regimen for at least 60 days before randomization, and willing to remain on this stable regimen for the duration of the study.
Exclusion criteria
✕. Patients with a known history of secondary or Mendelian causes of calcium nephrolithiasis
✕. Type I diabetes mellitus
✕. History of ketoacidosis
✕. Treatment with SGLT2 Inhibitor
✕. CKD (defined as CKD-EPI eGFR \<30 mL/min)
What they're measuring
1
Number of patients with radiologic stone recurrence