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

RecruitingPhase 3Ages 18 Years - anyAllInsel Gruppe AG, University Hospital Bern
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria: 1. Written, informed consent. 2. Age 18 years or older. 3. Recurrent kidney stone disease with 2 or more stone episodes in the last 10 years prior to randomization. 4. Last kidney stone containing 50% or more of CaOx, CaP or a mixture of both. 5. 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: 1. Known history of secondary or Mendelian causes of calcium nephrolithiasis 2. Type I diabetes mellitus 3. History of ketoacidosis 4. Chronic Kidney Disease (CKD) stage 4 or 5 (defined as CKD-EPI eGFR \<30 mL/min) 5. Kidney transplant recipient 6. History of recurrent urinary tract infections, defined as \>3 episodes within the year prior to randomization 7. Heart failure. Symptomatic patients with suspected heart failure must be evaluated before study enrollment 8. Treatment with an SGLT2i within 4 weeks prior to randomization. 9. Active cancer treatment 10. Pregnancy and/or breastfeeding. Women of childbearing potential (i.e., premenopausal women who have not undergone surgical sterilization and are sexually active with a male partner) must have a negative urine or blood pregnancy test prior to enrollment 11. Known allergy to the study drug 12. Inability to understand and follow the study procedures 13. Vulnerable individual, e.g. individual incapable of judgement or currently incarcerated or otherwise institutionalized (priosner), or refugee 14. Concomitant participation in another interventional clinical trial within 4 weeks prior to randomization and during the current trial 15. Prior enrollment in the EMPASTONE trial
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What it tests

  • Empagliflozin 10 MG
  • Placebo
  • Personalized dietary counseling
  • Generic dietary counseling
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Where

21 sites
University Hospital Amiens-Picardie
Amiens, France
Hôpital Tenon
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Charité University Medicine Berlin
Berlin, Germany
Università della Campania "Luigi Vanvitelli"
Naples, Italy
Verona University Hospital
Verona, Italy
Kantonsspital Aarau
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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