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

Completed · Phase 1 · Has a placebo group

Conditions studied: Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Calcium Phosphate

In brief

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.

Key facts

Study ID

NCT02096965

Run by

Mayo Clinic

People needed

20

Starts

2014-03-01

Expected to finish

2015-11-01

Last updated by the study team

2016-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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