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

Nephrolithiasis, Calcium Oxalate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096965
• Other study ID #: 11-001780
• Status: Completed
• Phase: Phase 1
• First received: March 24, 2014
• Last updated: March 28, 2016
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nephrolithiasis
• Nephrolithiasis, Calcium Oxalate
• Nephrolithiasis, Calcium Phosphate

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary calcium oxalate supersaturation (SS)	Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers.	Baseline to 3 weeks	No
Primary	Change in Calcium phosphate SS	Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers.	Baseline to three weeks	No