Recruiting
Early Phase 1

Empagliflozin

Sponsor:

University of Chicago

Code:

NCT07055282

Conditions

Kidney Stones

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Empagliflozin (Jardiance®)

Study Details

Brief 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.

Conditions

Kidney Stones

Study ID

NCT07055282

Start date

Nov 20, 2025

Status verified date

Sep, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Empagliflozin (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.

Primary outcome measure

  • Change in calcium phosphate [ Time Frame: 4 weeks ]
  • Change in urine citrate [ Time Frame: 4 weeks ]
  • Change in pH [ Time Frame: 4 weeks ]
  • Calcium oxalate supersaturation [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Megan Prochaska, MD

773-702-1000mprocha2@medicine.bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • kidney stones
  • SGLT2i
  • empagliflozin
  • calcium kidney stones
  • kidney stone
  • calcium kidney stone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-09-04.