Trial Outcomes & Findings for The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study (NCT NCT04818034)

Last Updated: 2025-10-16

Results Overview

The primary efficacy endpoint will be assessed by comparing previous 24hr urine cystine concentration data collected prior to study participation and 24hr urine concentration data collected after being on the study drug, specifically examining the content of cystine in the urine but not exclusively.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

1 month

Results posted on

2025-10-16

Participant Flow

The study team will identify the patients being treated for cystinuria within the study team's clinic. The study team will inform these patients of the study and provide them with the study details to allow further discussion and to answer any questions the patients might have.

There is only one arm for this study. Any patient willing to participate in this study will be in that arm and will be given the study drug Dapagliflozin.

Participant milestones

Participant milestones
Measure	Study Drug The study drug Dapagliflozin
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Drug n=10 Participants The study drug Dapagliflozin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: The analysis was specifically looking at cystine production in urine but other products were analyzed as well as shown in the table.

Outcome measures

Outcome measures
Measure	Study Drug n=10 Participants The study drug Dapagliflozin
24hr Urine Measurements of the Effect of SGLT-2 Inhibitor Therapy on Cystine Production in Urine in Patients With Cystinuria	999.3 24hr urine cystine concentration (mg) Standard Deviation 1.1

Adverse Events

Study Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marshall Stoller

University of California, San Francisco

Phone: 415-514-0918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place