SGLT2i in Kidney Stones

Launched by UNIVERSITY OF CHICAGO · Jul 3, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a medicine called empagliflozin, usually used to treat diabetes and heart problems, might help reduce factors that lead to kidney stones. The study focuses on people who have had calcium-based kidney stones, which are the most common types and include calcium oxalate or calcium phosphate stones. Researchers want to see if empagliflozin changes certain urine factors—like citrate levels and acidity—that influence stone formation, since earlier studies showed it might increase protective citrate in urine without changing acidity in people without kidney stones.

To take part, you need to be between 18 and 70 years old and have a history of either calcium oxalate or calcium phosphate stones, confirmed by a recent stone analysis. The study will include an equal number of men and women to better understand how the medicine works across sexes. Participants will take empagliflozin once daily for four weeks, and will collect urine samples before and after treatment to check for changes that might lower stone risk. The study will enroll 32 people in total. It’s important to note that people with other types of stones, serious kidney problems, or certain medical conditions won’t be eligible. Results from this early study could help guide larger trials to see if empagliflozin might be a useful option to prevent kidney stones in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Calcium phosphate (CaP) stone participants:
• • Age 18-70
• • History of at least one calcium phosphate (hydroxyapatite) stone
• • Defined as at least 50% of stone material on most recent stone analysis
• Calcium oxalate (CaOx) stone participants:
• • Age 18-70
• • History of at least one calcium oxalate stone
• • Defined as at least 50% of stone material on most recent stone analysis.
• • Other inclusion criteria considerations: The investigators will study balanced numbers of male and females. Prior studies did not have balanced representation of male and female sexes. In prior studies, less than 40% were female, or sex data is not presented. Study of both male and female sex is crucial with kidney stones and therapies that affect citrate and pH because there are well established epidemiologic differences in stone type and physiologic differences in acid-base handling by sex. Epidemiologically, younger women are more likely to have CaP stones, and this is likely because they have higher urine pH.
• Exclusion Criteria:
• • History of primarily brushite, uric acid, cysteine, or struvite stones
• • History of severe acid-base abnormality, very low (less than 100mg/day) or very high (greater than 1500mg/day) urine citrate
• • Participants who cannot stop diuretic medication or alkali supplementation for the course of the study period
• • Use of drugs that can directly affect proximal tubule function (e.g., topiramate)
• • Diagnosis of complete distal renal tubular acidosis
• • Diagnosis of chronic kidney disease (eGFR \<60 mL/min/1.73m²)