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

NCT02096965 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-03-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • John Lieske, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096965 on ClinicalTrials.gov