Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study
| Status: | Completed |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2014 |
| End Date: | November 2015 |
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.
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.
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.
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