Clinical Trial: TCUPS- Tolvaptan Use in Cyctinuria and Urolithiasis: A Pilot Study
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Use of Tolvaptan, a Vasopressin Antagonist, to Increase Urine Dilution and Reduce Cystine Urolithiasis Among Patients With Homozygous Cystinuria: a Pilot Investigation
Brief Summary: 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.
Detailed Summary:
Sponsor: Caleb Nelson
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Boston Children’s Hospital
Dates:
Date Received: July 21, 2015
Date Started: October 2016
Date Completion: October 2017
Last Updated: July 25, 2016
Last Verified: July 2016
