NCT07055282

SGLT2i in Kidney Stones

SGLT2i in Calcium Kidney Stones

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, prospective pilot study designed to evaluate the effects of the sodium-glucose co-transporter 2 inhibitor (SGLT2i), empagliflozin, on urinary risk factors in individuals with recurrent idiopathic calcium phosphate (CaP) or calcium oxalate (CaOx) kidney stones. Although empagliflozin is FDA-approved for other indications, it is being used off-label in our study to explore its potential for kidney stone prevention. The investigators' goal is to assess changes in urinary parameters relevant to stone formation, including citrate excretion, pH, and other metabolic markers. Eligible participants will be adults aged 18 to 70 years with a documented history of CaP or CaOx kidney stones. Participants will be asked to stop certain medications and supplements prior to and during the study period if deemed safe by their primary care provider or nephrologist. Each participant will complete two in-person study visits at the University of Chicago Clinical Research Center (CRC), a special research clinic, over approximately 4 weeks. They will also collect two 24-hour urine samples-one before starting the study drug and one at the end of the study. In addition, participants will take empagliflozin 10 mg once daily during the 4-week period and complete a brief phone or video check-in around the 2-week mark. Laboratory tests and physical measurements will be performed during each visit. All urine samples will be analyzed by a central clinical laboratory (Litholink), and select samples will be stored for future analysis. Participants will be compensated for completing the study. This pilot study is not intended to support a new drug indication or FDA labeling change. The findings will inform the design of a larger, hypothesis-driven study on the use of SGLT2 inhibitors in kidney stone prevention.

Conditions

• Kidney Stones

Interventions

Type	Name	Description
DRUG	Empagliflozin (Jardiance®)	Empagliflozin (Jardiance®), 10 mg tablet taken orally once daily for 4 weeks. Dispensed at baseline by the Investigational Drug Service. It will be administered at home by participants.

Timeline

• Start date: 2025-11-20
• Primary completion: 2027-11-01
• Completion: 2027-12-31
• First posted: 2025-07-08
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study