Actively Recruiting

Early Phase 1
Age: 18Years - 70Years
All Genders
NCT07055282

SGLT2i in Kidney Stones

Led by University of Chicago · Updated on 2026-01-12

32

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

SGLT2i in Kidney Stones

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • History of at least one calcium phosphate stone with at least 50% of stone material on recent analysis, or
  • History of at least one calcium oxalate stone with at least 50% of stone material on recent analysis
  • Balanced numbers of male and female participants
Not Eligible

You will not qualify if you...

  • History of mainly brushite, uric acid, cysteine, or struvite stones
  • History of severe acid-base abnormalities or urine citrate less than 100 mg/day or greater than 1500 mg/day
  • Inability to stop diuretics or alkali supplements during the study period
  • Use of drugs affecting proximal tubule function (e.g., topiramate)
  • Diagnosis of complete distal renal tubular acidosis
  • Diagnosis of chronic kidney disease with eGFR less than 60 mL/min/1.73m2

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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SGLT2i in Kidney Stones | DecenTrialz