An Early Phase 1 interventional study of Empagliflozin (Jardiance®) in Kidney Stones, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of Chicago · Early Phase 1, Interventional, and Treatment
Among 193 studies in Kidney Calculi with a site in United States — 42 open to participants now, 58 under way, none of them phase 3. Kidney Calculi · United States.
Among the 193 studies in Kidney Calculi with a site in United States, this one is the 96th largest by planned enrollment of the 165 interventional ones, is one of 19 that started in 2025, is one of 8 in phase 1, reaches primary completion later than 48 of the 57 other live ones, and was the 171st registered.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 32 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →42 of the 193 studies in Kidney Calculi with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 88 Kidney Calculi studies recruiting now, 48 (55%) set no upper age limit and 23 (26%) stop at 75 or younger; 6 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →193 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 19 started in 2025.
Median enrollment 47 across the 165 interventional studies, 122 across the 28 observational. Of the 116 that completed or were terminated, 51 (44%) have results posted.
34 of 193 have an industry lead sponsor. The 10 most frequent:
University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
University of Chicago has 9 studies filed under Kidney Calculi — fewer than ten, so there is no comparison to draw.
18 of the studies in Kidney Calculi with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07296835University of Kansas Medical CenterSurgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope | 2026-11 |
| NCT06576661University of Kansas Medical CenterEvaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes | 2026-11-01 |
| NCT04651088University of Texas Southwestern Medical CenterComparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet | 2026-12 |
| NCT05993546The Cleveland ClinicRandomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis | 2026-12 |
| NCT04333745University of Alabama at BirminghamInfluence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers | 2026-12-01 |
Among the 193 studies in Kidney Calculi with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Calcium phosphate (CaP) stone participants:
History of at least one calcium phosphate (hydroxyapatite) stone
Calcium oxalate (CaOx) stone participants:
History of at least one calcium oxalate stone
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Defined as \>50% calcium phosphate content on most recent stone analysis Age 18-70 years
Drug: Empagliflozin (Jardiance®)
Defined as \>50% calcium oxalate content on most recent stone analysis Age 18-70 years
Drug: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
Started Nov 2025 (actual). Primary completion is estimated for Nov 2028, 35 months after the start.
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Studies of the drug tested here: Empagliflozin