TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study

Completed · Not applicable

Conditions studied: Cystinuria

In brief

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.

Key facts

Study ID

NCT02538016

Run by

Caleb Nelson

People needed

4

Starts

2016-10-01

Expected to finish

2018-12-01

Last updated by the study team

2020-07-10

Who can join

Age: 12 and older, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females age 12 - 29 years
• Weight ≥ 25kg (55 lbs)
• Confirmed cystinuria diagnosis
• Specific blood test levels (done within the past 6 months)

You may not qualify if…

• 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

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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