Overview

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

Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Caleb Nelson
Collaborator:
Otsuka America Pharmaceutical
Treatments:
Tolvaptan
Criteria
Inclusion Criteria:

- Males and females age 12 - 29 years

- Weight ≥ 25kg (55 lbs)

- Confirmed cystinuria diagnosis

- Specific blood test levels (done within the past 6 months)

Exclusion Criteria:

- 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