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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystinuria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tolvaptan

Group Type OTHER

Tolvaptan

Intervention Type DRUG

Interventions

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Tolvaptan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No