NCT06653738 Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
| NCT ID | NCT06653738 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-07-02 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2026-07-02 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Daniel Fuster
PRINCIPAL INVESTIGATOR
Inselspital, Bern University Hospital
Frequently Asked Questions
Who can join the NCT06653738 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06653738 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06653738 currently recruiting?
Yes, NCT06653738 is actively recruiting participants. Contact the research team at daniel.fuster@unibe.ch for enrollment information.
Where is the NCT06653738 trial being conducted?
This trial is being conducted at Amiens, France, Paris, France, Paris, France, Berlin, Germany and 11 additional locations.
Who is sponsoring the NCT06653738 clinical trial?
NCT06653738 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Daniel Fuster at Inselspital, Bern University Hospital. The trial plans to enroll 400 participants.
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