Empagliflozin for people with calcium kidney stones
SGLT2i in Calcium Kidney Stones
This trial will test whether taking empagliflozin for four weeks changes urine chemicals linked to stone formation in adults who've had calcium kidney stones.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07055282 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective pilot enrolls 32 adults aged 18–70 with a history of calcium oxalate or calcium phosphate kidney stones. Participants (16 with CaOx and 16 with CaP) will take empagliflozin 10 mg daily for four weeks and provide 24-hour urine collections before and after treatment. Clinical labs and physical measures are obtained at two in-person visits at the University of Chicago Clinical Research Center, and all urine samples are analyzed centrally by Litholink. Certain medications and supplements will be held if deemed safe, and brief phone or video check-ins occur around two weeks to monitor safety and adherence.
Who should consider this trial
Good fit: Adults 18–70 with documented predominantly (≥50%) calcium oxalate or calcium phosphate stones who can attend two visits at the University of Chicago and stop certain medications as directed are ideal candidates.
Not a fit: People with non-calcium stones, advanced kidney disease, known contraindications to SGLT2 inhibitors, or who cannot travel to Chicago are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If empagliflozin raises urinary citrate or otherwise improves urine risk factors, it could lower the chance of recurrent calcium kidney stones and suggest a new prevention option.
How similar studies have performed: Prior studies in people without kidney stones showed empagliflozin increased urinary citrate without raising urine pH, but this effect has not been confirmed in patients with prior calcium stones.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.