Status:
COMPLETED
The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study
Lead Sponsor:
University of California, San Francisco
Conditions:
Cystinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
This is a single center, proof of concept prospective cohort trial designed to assess the effect of daily oral administration of dapagliflozin on cystine formation in freshly voided urine. Five subjec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04818034
Start Date
August 30 2021
End Date
April 28 2022
Last Update
October 16 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143