Empagliflozin and personalized diet for preventing calcium kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, 2-by-2 factorial phase 3 trial examines if daily empagliflozin 10 mg and individualized dietary counseling based on 24-hour urine results reduce radiologic stone recurrence over 3 years in adults with recurrent calcium kidney stones. Participants are assigned to empagliflozin or placebo and to personalized dietary counseling or generic counseling for 36 months. The study builds on prior data suggesting SGLT2 inhibitors may lower stone risk and uses 24-hour urine and dietary assessments to guide counseling strategies. Primary outcome is radiologic recurrence of stones at 3 years; secondary outcomes include effects of each intervention on stone recurrence and related biomarkers. Eligible adults must have had two or more stone episodes in the past decade and stones containing calcium oxalate or calcium phosphate.

Why it matters

Who can join: the full rules

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

Where it's running

• Kantonsspital Aarau
  Aarau, Switzerland Recruiting
• Kantonsspital Baden
  Baden, Switzerland Recruiting
• University Hospital Basel
  Basel, Switzerland Recruiting
• Inselspital Bern
  Bern, Switzerland Recruiting
• Kantonsspital Chur
  Chur, Switzerland Recruiting
• University Hospital Geneva (HUG)
  Geneva, Switzerland Recruiting

Study contacts

• Principal investigator: Daniel Fuster — Inselspital, Bern University Hospital
• Study coordinator: Daniel G Fuster, Prof MD
• Email: daniel.fuster@unibe.ch
• Phone: +41 31 632 31 44

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Investigating how the gut absorbs oxalate in kidney stone patients

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• Predicting kidney stone recurrence and complications using precision medicine

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.