TCUPS- Tolvaptan Use in Cyctinuria and Urolithiasis: A Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 12 - 29 |
| Updated: | 1/25/2019 |
| Start Date: | October 2016 |
| End Date: | December 2018 |
Use of Tolvaptan, a Vasopressin Antagonist, to Increase Urine Dilution and Reduce Cystine Urolithiasis Among Patients With Homozygous Cystinuria: a Pilot Investigation
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.
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.
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
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Caleb P Nelson, MD, MPH
Phone: 617-919-6352
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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