N/A
Completed N=4
TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study
Cystinuria
Source: ClinicalTrials.gov NCT02538016 ↗
Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Urinary Cystine Supersaturation (mg/L) at High Dose (Day7-8) — 70 mg/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Cystine Supersaturation (mg/L) at High Dose (Day7-8) |
70 | — |
| SECONDARY Urine Osmolality at High Dose (Day 8) |
141; 4.05; 102 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02538016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.