Empagliflozin for people with calcium kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.