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

NCT02096965 | Completed Phase 1

• 1 other identifier: 11-001780
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis, Calcium Oxalate; Nephrolithiasis, Calcium Phosphate

Keywords

Calcium oxalate; Calcium phosphate; Kidney stone

Outcome Measures

Primary Outcomes (2)

• Change in urinary calcium oxalate supersaturation (SS)

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

  Baseline to 3 weeks

• Change in Calcium phosphate SS

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

  Baseline to three weeks

Study Arms (2)

Tolvaptan first, then Placebo

EXPERIMENTAL

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

Drug: Tolvaptan; Drug: Placebo

Placebo first, then Tolvaptan

EXPERIMENTAL

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

Drug: Tolvaptan; Drug: Placebo

Interventions

Tolvaptan DRUG

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

Also known as: Samsca

Placebo first, then Tolvaptan; Tolvaptan first, then Placebo

Placebo DRUG

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

Placebo first, then Tolvaptan; Tolvaptan first, then Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Nephrolithiasis, Calcium Oxalate; Nephrolithiasis; Kidney Calculi

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John Lieske, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

US (1)