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SGLT-2 Inhibitor

SGLT-2 Inhibitor for Cystinuria

Phase 2
Waitlist Available
Led By Marshall Stoller, MD
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
History of previous cystine kidney stones
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year and 3 months
Awards & highlights

Study Summary

This trial will test whether or not SGLT-2 inhibitors can break or prevent the cystine bond on the molecular level such that cystine cannot precipitate in the urine, which would effectively treat or prevent cystinuria.

Who is the study for?
This trial is for adults over 18 with a history of cystine kidney stones and confirmed cystinuria. Participants must be able to consent and not have diabetes, be pregnant or likely to become so without birth control, seriously ill, non-English speaking, incarcerated, or unable to give informed consent.Check my eligibility
What is being tested?
The trial tests if Dapagliflozin, an FDA-approved drug for diabetes and heart failure that increases urine glucose levels can prevent or dissolve cystine stones in the kidneys by introducing enough glucose into the urine.See study design
What are the potential side effects?
While not specified here, common side effects of SGLT-2 inhibitors like Dapagliflozin include yeast infections due to sugar in the urine, urinary tract infections (UTIs), increased urination and risk of dehydration.

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.
Select...
I have had cystine kidney stones in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and 3 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 cystine stone size over time (1 year and 3 months)

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 is 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 Stoller, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Dapagliflozin (SGLT-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05058859 — Phase 2
Cystinuria Research Study Groups: Study Drug
Cystinuria Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT05058859 — Phase 2
Dapagliflozin (SGLT-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05058859 — Phase 2

Frequently Asked Questions

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

Which medical treatments does Dapagliflozin commonly help with?

"Dapagliflozin is most commonly used to treat pharmaceutical preparations. It can also be administered to treat other conditions like diet, exercise, and inadequate response to monotherapy."

Answered by AI

What is the FDA's stance on Dapagliflozin?

"Dapagliflozin's Phase 2 status indicates that, while there is some data supporting safety, there is none yet for efficacy. Thus, we've given it a score of 2."

Answered by AI

Are there any available openings for new participants in this clinical trial?

"As of right now, this study is not admitting any new patients into the trial. However, this may change in the future as the clinical trial was most recently edited on 9/13/2022. If you are looking for other trials to participate in, there are 4 cystinuria studies and 67 Dapagliflozin trials that are currently accepting patients."

Answered by AI

How many total subjects are included in this clinical research?

"This cystinuria study is no longer looking for candidates. The trial was originally posted on 8/1/2023 and was most recently updated on 9/13/2022. There are 4 other clinical trials actively admitting participants with cystinuria and 67 trials for Dapagliflozin that are still recruiting patients."

Answered by AI

Who else is applying?

What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Why did patients apply to this trial?

I’m tired of having kidney stones every two years.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics
2024. "Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05058859.
~7 spots leftby Aug 2025
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