Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Recruiting
Phase 3
Interventional Study
Kidney Stone
Nephrolithiasis
Dietary Exposure
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 400 (estimated)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Other
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About This Trial
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 diet…
Trial Locations
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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 …
Contacts