| NCT ID | NCT07055282 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Chicago |
| Condition | Kidney Stones |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2025-11-20 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Frequently Asked Questions
Who can join the NCT07055282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Kidney Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07055282 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07055282 currently recruiting?
Yes, NCT07055282 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Chicago to inquire about joining.
Where is the NCT07055282 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07055282 clinical trial?
NCT07055282 is sponsored by University of Chicago. The trial plans to enroll 32 participants.
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