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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Kidney Stone, Nephrolithiasis, Dietary Exposure

In brief

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.

Key facts

Study ID

NCT06653738

Run by

Insel Gruppe AG, University Hospital Bern

People needed

400

Starts

2026-07-02

Expected to finish

2030-09-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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)
• Kidney transplant recipient
• History of recurrent urinary tract infections, defined as >3 episodes within the year prior to randomization
• Heart failure. Symptomatic patients with suspected heart failure must be evaluated before study enrollment
• Treatment with an SGLT2i within 4 weeks prior to randomization.
• Active cancer treatment
• 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
• Known allergy to the study drug
• Inability to understand and follow the study procedures
• Vulnerable individual, e.g. individual incapable of judgement or currently incarcerated or otherwise institutionalized (priosner), or refugee
• Concomitant participation in another interventional clinical trial within 4 weeks prior to randomization and during the current trial
• Prior enrollment in the EMPASTONE trial

Where it is running

• Inselspital Bern — Bern, Switzerland (enrolling)
• 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
• University Hospital Basel — Basel, Switzerland
• Kantonsspital Chur — Chur, Switzerland
• Kantonsspital Fribourg — Fribourg, Switzerland
• University Hospital Geneva (HUG) — Geneva, Switzerland
• Lausanne University Hospital (CHUV) — Lausanne, Switzerland
• Kantonsspital Luzern — Lucerne, Switzerland
• Regionalspital Lugano — Lugano, Switzerland
• Kantonsspital Neuchâtel — Neuchâtel, Switzerland
• Kantonsspital Olten — Olten, Switzerland
• Kantonsspital St. Gallen — Sankt Gallen, Switzerland
• Kantonsspital Sion — Sion, Switzerland
• University Hospital Amiens-Picardie — Amiens, France
• Universitätsspital Zürich — Zurich, Switzerland

Full record on ClinicalTrials.gov

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