Health TrialsbyHealthPanel

SGLT2i in Kidney Stones

ConditionKidney Stones
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Chicago

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Age 18-70

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: CaP (Calcium Phosphate) stone patientsActive comparator 1 intervention
Group B: CaOx (Calcium Oxalate) stone patientsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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