NCT02096965

Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM) regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect during the night. To this end, a higher dose is used in the morning, with a lower dose in the afternoon.

Conditions

• Nephrolithiasis, Calcium Oxalate
• Nephrolithiasis, Calcium Phosphate

Interventions

Type	Name	Description
DRUG	Tolvaptan	Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
DRUG	Placebo	Patients will receive daily dose at 8 AM and at 4 PM.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-03-26
• Last updated: 2016-03-30

Locations

1 site across 1 country: United States