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The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study


Description

Cystinuria is an inherited autosomal recessive disorder of the kidney that is the result of an inability to reabsorb cystine from the urine. Supersaturation of cystine in the urine produces crystals that precipitate and form stones in the kidney, which can be a cause of obstruction, infection, and chronic kidney disease. Cystine stones constitute a major health challenge for affected individuals with cystinuria because of the frequent recurrence of painful symptoms and the current absence of effective, patient-accepting treatment. A mainstay of therapy is breaking or preventing the cystine bond on the molecular level such that cystine (which is formed from the joining of two cysteine amino acids and their corresponding sulfur atoms) cannot precipitate in the urine. It is hypothesized that a glucose molecule may be able to do this if introduced into the urine. SGLT-2 inhibitors are a class of drug that are FDA approved to treat diabetes mellitus (DM) and heart failure by inhibiting an

Trial Eligibility

Inclusion Criteria: * males and females age 18 or older * documented cystinuria on prior 24-hour urine collection and/or stone analysis * history of previous cystine kidney stones * able and willing to provide consent Exclusion Criteria: * prior diagnosis of diabetes mellitus (type I or type II) * current SGLT-2 inhibitor administration at the time of screening * SGLT-2 inhibitor administration within the last year prior to screening * vulnerable populations including incarceration status * anticipation of pregnancy during the study duration * unable to give informed consent * non-English primary language * pregnancy, lactation, or child- bearing age without birth control devices * serious illness likely to cause death within the next 5 years.

Study Info

Organization

University of California, San Francisco


Primary Outcome

Change in cysteine level in freshly voided urine


Outcome Timeframe Samples collected at Initial visit and Day 7 visit, preserved and stored; mass spectometry analysis done over the course of 6 months

NCTID NCT04818034

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2025-05-02

Completion Date 2025-12-31

Enrollment Target 10

Interventions

DRUG Dapagliflozin

Locations Recruiting

University of California, San Francisco

United States, California, San Francisco


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