Clinical Trial

SGLT2i in Kidney Stones

Recruiting Early Phase 1
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Summary
This study is looking at whether empagliflozin, a medication typically used for diabetes and heart conditions, may affect factors that contribute to kidney stone formation. The research focuses on people who have had calcium-based kidney stones, i.e. calcium oxalate or calcium phosphate stones. Previous studies in those without kidney stones found that empagliflozin increased urinary citrate levels without raising urine pH. The investigators are testing whether similar effects occur in people with a history of kidney stones. Participants will take empagliflozin daily for 4 weeks. The investigators will collect 24-hour urine samples before and after treatment to measure various factors that influence stone formation, including citrate levels, pH, and calculated stone formation risk. The investigators will enroll 32 participants: 16 with a history of calcium oxalate stones and 16 with calcium phosphate stones. Results from this study may inform future larger clinical trials investigating empagliflozin as a kidney stone prevention strategy.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-07-03; most recent amendment 2026-01-08.
Status change: Not Yet Recruiting → Recruiting 2026-01-08
Trial Details
NCT Number NCT07055282
Lead Sponsor University of Chicago
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Kidney Stones
Enrollment 32 participants
Start Date 2025-11-20
Primary Completion 2027-11-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-12