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

RecruitingPhase 3

Sponsor: Insel Gruppe AG, University Hospital Bern

Conditions: Kidney Stone, Nephrolithiasis, Dietary Exposure

Interventions: Empagliflozin 10 MG, Placebo, Personalized dietary counseling, Generic dietary counseling

Countries: France, Germany, Italy, Switzerland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (21)

Amiens, France
Paris, France
Paris, France
Berlin, Germany
Naples, Italy
Verona, Italy
Aarau, Switzerland
Baden, Switzerland
Basel, Switzerland
Bern, Switzerland
Chur, Switzerland
Fribourg, Switzerland
Geneva, Switzerland
Lausanne, Switzerland
Lucerne, Switzerland
Lugano, Switzerland
Neuchâtel, Switzerland
Olten, Switzerland
Sankt Gallen, Switzerland
Sion, Switzerland
Zurich, Switzerland