The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine

Status Recruiting

Clinical Trial 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 that precipitate and form stones in the kidney, which can be a cause of obstruction, infection, and chronic kidney disease. Cystine stones constitute a major health challenge for affected individuals with cystinuria because of the frequent recurrence of painful symptoms and the current absence of effective, patient-accepting treatment. A mainstay of therapy is breaking or preventing the cystine bond on the molecular level such that cystine (which is formed from the joining of two cysteine amino acids and their corresponding sulfur atoms) cannot precipitate in the urine. It is hypothesized that a glucose molecule may be able to do this if introduced into the urine. SGLT-2 inhibitors are a class of drug that are FDA approved to treat diabetes mellitus (DM) and heart failure by inhibiting an enzyme in the kidney that allows for reabsorption of glucose from the urine. This effectively increases the concentration of glucose in the urine. Our hypothesis suggests that administration of this drug to patients with cystine will introduce sufficient glucose into the urine to prevent the formation of cystine stones. To date, there has been no published data on the effectiveness of this therapy for this indication, although the dosage and administration would be identical to that already approved by the FDA for the treatment of DM and heart failure.

Clinical Trial 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 subjects are planned, each with previously diagnosed cystinuria and without current treatment except with potassium citrate medication. Total duration of subject participation with be up to four weeks. Total duration of the study is expected to be 6 months. ;

Study Design

Related Conditions & MeSH terms

Cystinuria

Clinical Trial Details

NCT number	NCT04818034
Study type	Interventional
Source	University of California, San Francisco
Contact	Victoria Hogue
Phone	415-302-7443
Email	Victoria.Hogue@ucsf.edu
Status	Recruiting
Phase	Phase 2
Start date	May 2, 2025
Completion date	June 1, 2026

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See also
Status	Clinical Trial	Phase
Completed	`NCT02120105` - Cystine Capacity Clinical Study (CysCap)
Completed	`NCT02538016` - TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study	N/A
Recruiting	`NCT06065852` - National Registry of Rare Kidney Diseases
Recruiting	`NCT00169806` - Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis	N/A
Completed	`NCT03663855` - Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria	Phase 2
Recruiting	`NCT02780297` - Prospective Research Rare Kidney Stones (ProRKS)
Recruiting	`NCT02026388` - Rare Kidney Stone Consortium Biobank
Withdrawn	`NCT04137978` - Study Evaluating Patients With Cystinuria	Phase 2/Phase 3
Recruiting	`NCT02942420` - Bucillamine Phase 2 Trial in Patients With Cystinuria	Phase 2
Completed	`NCT05048563` - Registry of Thiola EC Therapy
Not yet recruiting	`NCT04147871` - Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children	Phase 2/Phase 3
Completed	`NCT02125721` - Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria	Phase 4
Active, not recruiting	`NCT02910531` - Lipoic Acid Supplement for Cystine Stone	Phase 2
Recruiting	`NCT00588562` - Rare Kidney Stone Consortium Patient Registry
Completed	`NCT02124395` - Health-related Quality of Life in Rare Kidney Stone
Not yet recruiting	`NCT05058859` - Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics	Phase 2
Active, not recruiting	`NCT03539926` - This Study Evaluates the Superiority of Daily Self-pH Monitorization of Lit-control®pH Meter Compared to the Monitorization of Reactive Strips (Standard of Care).	N/A
Completed	`NCT00381849` - Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones	Phase 1/Phase 2
Completed	`NCT03836144` - Effect of Urine Alkalinazation on Urinary Inflammatory Markers in Patients With Cystinuria

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms