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

Primary Purpose

Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Calcium Phosphate

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tolvaptan

Placebo

About this trial

This is an interventional basic science trial for Nephrolithiasis, Calcium Oxalate focused on measuring Calcium oxalate, Calcium phosphate, Kidney stone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tolvaptan first, then Placebo

Placebo first, then Tolvaptan

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in urinary calcium oxalate supersaturation (SS)

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

Change in Calcium phosphate SS

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02096965

First Posted

March 24, 2014

Last Updated

March 28, 2016

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02096965

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Calcium Phosphate

Keywords

Calcium oxalate, Calcium phosphate, Kidney stone

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tolvaptan first, then Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo first, then Tolvaptan

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tolvaptan

Other Intervention Name(s)

Samsca

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in urinary calcium oxalate supersaturation (SS)

Description

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

Time Frame

Baseline to 3 weeks

Title

Change in Calcium phosphate SS

Description

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

Time Frame

Baseline to three weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Lieske, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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