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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
John Lieske, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02096965
First received: March 24, 2014
Last updated: March 25, 2014
Last verified: March 2014
  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: Double Blind (Subject, Caregiver, 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 Mayo Clinic:

Primary Outcome Measures:
  • Change in urinary calcium oxalate supersaturation (SS) [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]
    Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers.

  • Change in Calcium phosphate SS [ Time Frame: Baseline to three weeks ] [ Designated as safety issue: No ]
    Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers.


Estimated Enrollment: 20
Study Start Date: March 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096965

Contacts
Contact: Ruth A. Kraft 507-266-8133 kraft.ruth@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ruth A. Kraft, Research Coordinator    507-266-8133    kraft.ruth@mayo.edu   
Principal Investigator: Dr. John Lieske, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John Lieske, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: John Lieske, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02096965     History of Changes
Other Study ID Numbers: 11-001780
Study First Received: March 24, 2014
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Calcium oxalate
Calcium phosphate
Kidney stone

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis

ClinicalTrials.gov processed this record on October 01, 2014