Kidney StonesEarly Phase 1NCT07055282
SGLT2i in Kidney Stones
A Early Phase 1 study testing Empagliflozin (Jardiance®) in people with Kidney Stones, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Empagliflozin (Jardiance®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2025to 1 Nov 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Megan Prochaska, MD, 773-702-1000 ext. 45488, mprocha2@medicine.bsd.uchicago.edu
About this study
Official title: 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.
Read more
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.
Read the detailed description
This is a single-center, prospective pilot study designed to evaluate the effects of the sodium-glucose co-transporter 2 inhibitor (SGLT2i), empagliflozin, on urinary risk factors in individuals with recurrent idiopathic calcium phosphate (CaP) or calcium oxalate (CaOx) kidney stones. Although empagliflozin is FDA-approved for other indications, it is being used off-label in our study to explore its potential for kidney stone prevention. The investigators' goal is to assess changes in urinary parameters relevant to stone formation, including citrate excretion, pH, and other metabolic markers.
Eligible participants will be adults aged 18 to 70 years with a documented history of CaP or CaOx kidney stones. Participants will be asked to stop certain medications and supplements prior to and during the study period if deemed safe by their primary care provider or nephrologist.
Each participant will complete two in-person study visits at the University of Chicago Clinical Research Center (CRC), a special research clinic, over approximately 4 weeks. They will also collect two 24-hour urine samples-one before starting the study drug and one at the end of the study. In addition, participants will take empagliflozin 10 mg once daily during the 4-week period and complete a brief phone or video check-in around the 2-week mark.
Laboratory tests and physical measurements will be performed during each visit. All urine samples will be analyzed by a central clinical laboratory (Litholink), and select samples will be stored for future analysis. Participants will be compensated for completing the study.
This pilot study is not intended to support a new drug indication or FDA labeling change. The findings will inform the design of a larger, hypothesis-driven study on the use of SGLT2 inhibitors in kidney stone prevention.
- Conditions
- Kidney Stones
- Being tested
- Empagliflozin (Jardiance®)
- Keywords
- kidney stones, SGLT2i, empagliflozin, calcium kidney stones, kidney stone, calcium kidney stone
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| CaP (Calcium Phosphate) stone patients | Active comparator | Defined as >50% calcium phosphate content on most recent stone analysis Age 18-70 years Receives: Drug: Empagliflozin (Jardiance®) |
| CaOx (Calcium Oxalate) stone patients | Active comparator | Defined as >50% calcium oxalate content on most recent stone analysis Age 18-70 years Receives: Drug: Empagliflozin (Jardiance®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in calcium phosphate
Calcium phosphate supersaturation will be measured or calculated at baseline and study completion. The investigators will calculate change in calcium phosphate supersaturation for all participants and within each group.
Measured: 4 weeks
Change in urine citrate
Urine citrate will be measured or calculated at baseline and study completion. The investigators will calculate change in urine citrate for all participants and within each group.
Measured: 4 weeks
Change in pH
pH will be measured or calculated at baseline and study completion. The investigators will calculate change in pH for all participants and within each group.
Measured: 4 weeks
Calcium oxalate supersaturation
Calcium oxalate supersaturation will be measured or calculated at baseline and study completion. The investigators will calculate change in calcium oxalate supersaturation for all participants and within each group.
Measured: 4 weeks
Secondary outcomes (4)
Change in 24-hour urine citrate excretion (mg/day) from baseline to 4 weeks
24-hour urine citrate excretion will be measured at baseline and study completion. The change from baseline to 4 weeks will be calculated for each participant and compared between CaP and CaOx stone groups.
Measured: 4 weeks
Change in urine pH from baseline to 4 weeks
Urine pH will be measured at baseline and study completion. The change from baseline to 4 weeks will be calculated for each participant and compared between groups.
Measured: 4 weeks
Change in calcium phosphate supersaturation from baseline to 4 weeks
Calcium phosphate supersaturation will be calculated using EQUIL2 at baseline and 4 weeks. The change will be calculated for each participant and compared between groups.
Measured: 4 weeks
Change in calcium oxalate supersaturation from baseline to 4 weeks
Calcium oxalate supersaturation will be calculated using EQUIL2 at baseline and 4 weeks. The change will be calculated for each participant and compared between groups.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start20 Nov 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055282
- Sponsor's protocol ID
- IRB25-0673
- Other IDs
- 1R01DK144310
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No