RecruitingEarly Phase 1NCT07055282

SGLT2i in Kidney Stones

SGLT2i in Calcium Kidney Stones


Sponsor

University of Chicago

Enrollment

32 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria6

  • 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)

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Interventions

DRUGEmpagliflozin (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.


Locations(1)

University of Chicago

Chicago, Illinois, United States

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NCT07055282


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