From Idea to Impact: Your Partner in Clinical Research That Matters
Official Title
Randomized placebo-controlled trial to assess efficacies of EMPAgliflozin and personalized dietary counseling for kidney STONE prevention in patients with calcium kidney stones (EMPASTONE)
Principal Investigator
Summary
This randomized trial uses a 2×2 factorial design to evaluate whether the SGLT2 inhibitor empagliflozin and individualized dietary counseling can reduce the recurrence of calcium kidney stones. The dietary intervention is tailored using 24-hour urine analyses and detailed dietary assessments.
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Study interventions:
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Empagliflozin 25 mg taken orally once daily for 36 months
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Personalized dietary counseling for 36 months.
Control interventions:
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Placebo taken orally once daily for 36 months
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Generic dietary counseling for 36 months
Prof. Daniel Fuster, Interim Co-Director of the Clinic of Nephrology and Hypertension, Inselspital, Bern
Clinical Study Management & Regulatory Affairs
Notably, the study achieved Ethics Committee approval in early January 2026 within an exceptionally short timeframe, underscoring the efficiency and expertise of the DCR Clinical Study Management team, which led protocol development and regulatory submissions.
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The DCR PPI team contributed by establishing a panel of patients and members of the public, and organizing involvement activities, ensuring PPI contributors could meaningfully shape the project and strengthen its patient-centered approach. First patient inclusion is planned for early summer 2026, with continued support from the DCR’s multidisciplinary capabilities.
The DCR Monitoring team contributed to the development of a risk‑based monitoring strategy and related on-site monitoring procedures, in preparation for ethical submission.
In the future, the monitoring team will continue supporting the trial by defining a strategy for centralized monitoring (as part of the overall risk-based monitoring strategy), initiating the sites following approval by the Ethics Committee and conducting on-going monitoring to ensure data integrity and the protection of participants’ rights and safety.
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