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

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.

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Key information

Conditions

Nephrolithiasis, Calcium Oxalate Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Nephrolithiasis, Calcium Phosphate Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

History of calcium oxalate or calcium phosphate stone.
Good renal function

Exclusion criteria

History of hypo-or hypernatremia.
History of hypotension or orthostatic dizziness.
Clinical history of congestive heart failure.

Treatment and study plan

Tolvaptan

Drug

Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).

Other names: Samsca

Placebo

Drug

Patients will receive daily dose at 8 AM and at 4 PM.

Primary outcomes

Change in urinary calcium oxalate supersaturation (SS)

Time frame: Baseline to 3 weeks

Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers.
Change in Calcium phosphate SS

Time frame: Baseline to three weeks

Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 26, 2014
Registry last updated: Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed