Effect of a diabetes drug on kidney stone formation in cystinuria patients
The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study
This study is testing if a diabetes drug can help people with cystinuria reduce the formation of kidney stones.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04818034 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of dapagliflozin, an SGLT-2 inhibitor, on cystine stone formation in patients diagnosed with cystinuria. It is a single-center, proof of concept trial involving five participants who will receive daily oral doses of the medication for up to four weeks. The primary goal is to assess changes in cystine levels in freshly voided urine, with a total study duration of six months. Participants must have a history of cystine kidney stones and are not currently on any other treatments for their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a documented history of cystinuria and previous cystine kidney stones.
Not a fit: Patients with a prior diagnosis of diabetes mellitus or those currently taking SGLT-2 inhibitors will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from recurrent cystine kidney stones.
How similar studies have performed: While the use of SGLT-2 inhibitors for cystinuria is a novel approach, similar studies have shown promise in other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Marshall Stoller — University of California, San Francisco
- Study coordinator: Victoria Hogue
- Email: Victoria.Hogue@ucsf.edu
- Phone: 415-302-7443
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.