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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Nephrolithiasis, Calcium Oxalate; Nephrolithiasis, Calcium Phosphate

Treatments: Drug: Placebo; Drug: Tolvaptan

Study type: Interventional

Funder types: Other

Identifiers

NCT02096965

11-001780

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Tolvaptan first, then Placebo

Experimental group

Description:

Tolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period)

Treatment:

Drug: Placebo

Drug: Tolvaptan

Placebo first, then Tolvaptan

Experimental group

Description:

Placebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period)

Treatment:

Drug: Placebo

Drug: Tolvaptan