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

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to see if a medication called empagliflozin, along with personalized dietary counseling, can help prevent kidney stones from coming back in patients who have had multiple episodes of kidney stones. The trial will involve people who are 18 years or older and have had at least two kidney stone incidents in the past 10 years, with specific types of stones made mostly of calcium. Participants will either receive the empagliflozin medication or a placebo (a sugar pill) for three years, along with tailored dietary advice based on their individual needs.

To be eligible, participants must be in good health, not have certain serious conditions like type 1 diabetes or chronic kidney disease, and be able to follow the study's guidelines. The trial is currently not recruiting participants, but once it begins, those who join can expect to take the medication daily and receive personalized advice on their diet for three years. This study aims to find effective ways to reduce the risk of kidney stones, which can be painful and disruptive to daily life.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Written, informed consent.
• • 2. Age 18 years or older.
• • 3. Recurrent kidney stone disease (2 or more stone episodes in the last 10 years).
• • 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. Patients with a known history of secondary or Mendelian causes of calcium nephrolithiasis
• • 2. Type I diabetes mellitus
• • 3. History of ketoacidosis
• • 4. Treatment with SGLT2 Inhibitor
• • 5. CKD (defined as CKD-EPI eGFR \<30 mL/min)
• • 6. Kidney transplant recipient
• • 7. History of recurrent urinary tract infections (\>3 episodes/year)
• • 8. Active cancer treatment
• • 9. Less than 3-year life expectancy
• • 10. Pregnancy and breastfeeding
• • 11. Inability to understand and follow the study protocol
• • 12. Known allergy to the study drug
• • 13. Concomitant participation in another interventional clinical trial