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From Idea to Impact: Your Partner in Clinical Research That Matters
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EMPASTONE: Overview
DCR INVOLVEMENT
Clinical Investigation Unit
Clinical Study Management
Data Management*
Monitoring
Statistics and Methodology
Patient and Public Involvement
 
Divisions marked red have supported the trial.

EMPASTONE TRIAL

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)

Sponsor

Insel Gruppe AG

 

Represented by Prof. Daniel Fuster, Interim Co-Director of the Clinic of Nephrology and Hypertension, Inselspital, Bern

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:

  • Empagliflozin 25 mg taken orally once daily for 36 months

 

Control interventions:

  • Placebo taken orally once daily for 36 months

  • Generic dietary counseling for 36 months

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Clinical Study Management & Regulatory Affairs

Notably, the study achieved Ethics Committee approval in early January 2026 within an exceptionally short timeframe and obtained Swissmedic approval upon first submission without any charges, underscoring the efficiency and expertise of the DCR Clinical Study Management team, which led protocol development and regulatory submissions.

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Monitoring

The DCR Monitoring team contributed to the development of a risk‑based monitoring strategy and related on-site monitoring procedures, in preparation for the submission to the Ethics Committee. 

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The Data Management at DCR Bern provides three databases (DBs) for the EMPASTONE trial: The main DB for data collection, a contact information DB, and an IMP DB containing the list of IMPs with their number, content (Empagliflozin or Placebo), expiration date and site-specific availability. The main DB contains among others the online randomization implemented as two consecutive steps and supports IMP dispensing by dynamically retrieving the next available IMP number from the IMP DB.

Data Management
Patient & Public
Involvement

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. 

DCR Collaboration

The DCR supported the successful launch of the EMPASTONE project, led by Prof. Daniel Fuster from Department of Nephrology and Hypertension, Inselspital. The DCR also contributed to the preparation and submission of the successful grant application to the Swiss National Science Foundation IICT Call 2024. With nearly CHF 3.5 million in funding, EMPASTONE is a multicenter, double-blind, placebo-controlled trial investigating whether empagliflozin combined with personalized dietary counseling can reduce the recurrence of calcium-based kidney stones. The DCR continues to provide key support in the implementation and coordination of the study.

 

Learn more about the EMPASTONE trial here.

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