TCUPS- Tolvaptan Use in Cyctinuria and Urolithiasis: A Pilot Study (TCUPS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The goal of this research project is to establish that in short-term use, tolvaptan is a safe and potentially effective new therapy for cystinuria, by conducting a short-term pilot study of the safety and tolerability of this drug, and assess impact on urinary stone risk parameters, among adolescent and young adult patients with clinical cystinuria.
The short-term safety profile of tolvaptan therapy in adolescent patients with cystinuria will be measured by daily hospital visits where they will be monitored for alterations in blood pressure. [ Time Frame: 2 years ]
The short-term safety profile of tolvaptan therapy in adolescent patients with cystinuria will be measured by daily blood tests. [ Time Frame: 2 years ]
Secondary Outcome Measures :
The short-term effect of tolvaptan on urinary risk factors for urolithiasis in adolescent patients with cystinuria will be measured by daily composite urine analysis. [ Time Frame: 2 years ]
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Layout table for eligibility information
Ages Eligible for Study:
12 Years to 29 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Males and females age 12 - 29 years
Weight ≥ 25kg (55 lbs)
Confirmed cystinuria diagnosis
Specific blood test levels (done within the past 6 months)
Concurrent non-renal disease that might increase risk of complications due to aquaresis
Liver or biliary disease (chronic or acute)
Malabsorption syndrome or other gastrointestinal condition that may interfere with response to therapy
Non-cutaneous malignancy within last 5 years
History of adverse reaction or allergy to Tolvaptan or other arginine vasopressin V2-receptor antagonists