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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02096965
First Posted: March 26, 2014
Last Update Posted: March 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Lieske, Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Nephrolithiasis, Calcium Oxalate Nephrolithiasis, Calcium Phosphate Drug: Tolvaptan Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study

Resource links provided by NLM:


Further study details as provided by John Lieske, Mayo Clinic:

Primary Outcome Measures:
  • Change in urinary calcium oxalate supersaturation (SS) [ Time Frame: Baseline to 3 weeks ]
    Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers.

  • Change in Calcium phosphate SS [ Time Frame: Baseline to three weeks ]
    Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers.


Enrollment: 20
Study Start Date: March 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolvaptan first, then Placebo
Tolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period)
Drug: Tolvaptan
Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
Other Name: Samsca
Drug: Placebo
Patients will receive daily dose at 8 AM and at 4 PM.
Experimental: Placebo first, then Tolvaptan
Placebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period)
Drug: Tolvaptan
Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
Other Name: Samsca
Drug: Placebo
Patients will receive daily dose at 8 AM and at 4 PM.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096965


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John Lieske, MD Mayo Clinic
  More Information

Responsible Party: John Lieske, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02096965     History of Changes
Other Study ID Numbers: 11-001780
First Submitted: March 24, 2014
First Posted: March 26, 2014
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by John Lieske, Mayo Clinic:
Calcium oxalate
Calcium phosphate
Kidney stone

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs