Nephrolithiasis, Calcium Oxalate, Nephrolithiasis, Calcium Phosphate
Conditions
Keywords
Calcium oxalate, Calcium phosphate, Kidney stone
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.
Interventions
DRUGTolvaptan
Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
DRUGPlacebo
Patients will receive daily dose at 8 AM and at 4 PM.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary calcium oxalate supersaturation (SS) | Baseline to 3 weeks | Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers. |
| Change in Calcium phosphate SS | Baseline to three weeks | Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers. |
Countries
United States
Outcome results
None listed