SGLT2i in Calcium Kidney Stones

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.

CT.gov Identifier
NCT07055282
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
National Institutes of Health (NIH), University of Chicago
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Chronic Kidney Disease
Study Drug
Empagliflozin (Jardiance®)
Genes
N/A
Study Dates
Nov 2025 - Nov 2027
Sex
Female & Male
Age
18 - 70 Years
Inclusion and Exclusion 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)

Protocol 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.

Study Locations

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