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

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

Sponsors

Lead sponsor: Mayo Clinic

Source Mayo Clinic
Brief 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.

Overall Status Completed
Start Date March 2014
Completion Date November 2015
Primary Completion Date November 2015
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in urinary calcium oxalate supersaturation (SS) Baseline to 3 weeks
Change in Calcium phosphate SS Baseline to three weeks
Enrollment 20
Condition
Intervention

Intervention type: Drug

Intervention name: Tolvaptan

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

Other name: Samsca

Intervention type: Drug

Intervention name: Placebo

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

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
John Lieske, MD Principal Investigator Mayo Clinic
Location
facility
Mayo Clinic in Rochester
Location Countries

United States

Verification Date

March 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Mayo Clinic

Investigator full name: John Lieske

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Tolvaptan first, then Placebo

Arm group type: Experimental

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

Arm group label: Placebo first, then Tolvaptan

Arm group type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Basic Science

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov