SGLT2i in Kidney Stones

NCT07055282 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: IRB25-06731R01DK144310
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones

Keywords

kidney stones; SGLT2i; empagliflozin; calcium kidney stones; kidney stone; calcium kidney stone

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  4 weeks

Secondary Outcomes (4)

• Change in 24-hour urine citrate excretion (mg/day) from baseline to 4 weeks

  4 weeks

• Change in urine pH from baseline to 4 weeks

  4 weeks

• Change in calcium phosphate supersaturation from baseline to 4 weeks

  4 weeks

• Change in calcium oxalate supersaturation from baseline to 4 weeks

  4 weeks

Study Arms (2)

CaP (Calcium Phosphate) stone patients

ACTIVE COMPARATOR

Defined as \>50% calcium phosphate content on most recent stone analysis Age 18-70 years

Drug: Empagliflozin (Jardiance®)

CaOx (Calcium Oxalate) stone patients

ACTIVE COMPARATOR

Defined as \>50% calcium oxalate content on most recent stone analysis Age 18-70 years

Drug: Empagliflozin (Jardiance®)

Interventions

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.

CaOx (Calcium Oxalate) stone patients; CaP (Calcium Phosphate) stone patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Chicago: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 8, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)