SGLT2i in Kidney Stones

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07055282
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Kidney Stones

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin (Jardiance®) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 20, 2025
Status verified
Jan 2026
Primary completion
Nov 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in calcium phosphate [ Time Frame: 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Megan Prochaska, MD
[email protected]
(773) 702-1000

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By research site
University of Chicago· Chicago, IL

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