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SGLT-2 Inhibitor

SGLT2 Inhibitors for Cystinuria

Phase 2
Recruiting
Led By Marshall Stoller
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of previous cystine kidney stones
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up samples collected at initial visit and day 7 visit, preserved and stored; mass spectometry analysis done over the course of 6 months
Awards & highlights

Study Summary

This trial will test whether or not a diabetes medication can also prevent the formation of kidney stones in people with a genetic disorder that makes them more likely to form these stones.

Who is the study for?
This trial is for adults over 18 with cystinuria, documented by urine tests or stone analysis, and a history of cystine kidney stones. It's not for non-English speakers, pregnant or lactating individuals without birth control, those unable to consent, prisoners, diabetics, current or recent SGLT-2 inhibitor users, or anyone with serious illness likely to cause death within 5 years.Check my eligibility
What is being tested?
The study is testing if Dapagliflozin (an FDA-approved diabetes drug) can prevent the formation of cystine stones in the kidneys by increasing glucose levels in urine. This preliminary study will explore whether this treatment could be an effective option for patients with cystinuria.See study design
What are the potential side effects?
Potential side effects of Dapagliflozin may include dehydration and low blood pressure due to increased urination; yeast infections; urinary tract infections; changes in urination; and possible increase in cholesterol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had cystine kidney stones in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~samples collected at initial visit and day 7 visit, preserved and stored; mass spectometry analysis done over the course of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and samples collected at initial visit and day 7 visit, preserved and stored; mass spectometry analysis done over the course of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cysteine level in freshly voided urine

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study DrugExperimental Treatment1 Intervention
The study drug Dapagliflozin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64440

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,545 Total Patients Enrolled
2 Trials studying Cystinuria
60 Patients Enrolled for Cystinuria
Marshall StollerPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Dapagliflozin (SGLT-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04818034 — Phase 2
Cystinuria Research Study Groups: Study Drug
Cystinuria Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT04818034 — Phase 2
Dapagliflozin (SGLT-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04818034 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical applications does Dapagliflozin commonly treat?

"Dapagliflozin is frequently employed as a pharmaceutical remedy and holds efficacy in treating conditions such as dietary habits, regular physical activity, and failure to respond satisfactorily to singular therapies."

Answered by AI

What is the capacity of this research endeavor?

"Affirmative. Information hosted on clinicaltrials.gov reveals that the trial, which was initially posted in May 2nd of 2023, is still recruiting patients. A single medical centre needs to identify 10 individuals for this investigation."

Answered by AI

Has the U.S. Food and Drug Administration authorized Dapagliflozin?

"The safety of Dapagliflozin warrants a rating of 2 since this is a Phase II trial, indicating evidence for safety but no data to support efficacy."

Answered by AI

Would you say that this research is pioneering in nature?

"Since 2014, AstraZeneca has been researching Dapagliflozin. This drug received N/A approval following the first trial in 2014 conducted with 700 participants. Currently, over 50 countries across 235 cities are conducting 63 active studies on this medication."

Answered by AI

Is there still available capacity for enrolment in this research endeavor?

"According to the official website, clinicaltrials.gov recruiting is still underway for this research project that was initially posted on May 2nd 2023 and last refreshed on October 4th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study
2025. "The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04818034.
~7 spots leftby Dec 2025
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