Kidney Stones Clinical Trials

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SGLT2i in Calcium Kidney Stones

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

‣ 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.

Locations
United States
Illinois
University of Chicago
RECRUITING
Chicago
Time Frame
Start Date: 2025-11-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 32
Treatments
Active_comparator: CaP (Calcium Phosphate) stone patients
Defined as \>50% calcium phosphate content on most recent stone analysis Age 18-70 years
Active_comparator: CaOx (Calcium Oxalate) stone patients
Defined as \>50% calcium oxalate content on most recent stone analysis Age 18-70 years
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Leads: University of Chicago

This content was sourced from clinicaltrials.gov