Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Calcium phosphate SS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of calcium oxalate or calcium phosphate stone.
- •Good renal function
排除标准
- •History of hypo-or hypernatremia.
- •History of hypotension or orthostatic dizziness.
- •Clinical history of congestive heart failure.
研究组 & 干预措施
Tolvaptan first, then Placebo
Tolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period)
干预措施: Tolvaptan (Drug)
Tolvaptan first, then Placebo
Tolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period)
干预措施: Placebo (Drug)
Placebo first, then Tolvaptan
Placebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period)
干预措施: Tolvaptan (Drug)
Placebo first, then Tolvaptan
Placebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Calcium phosphate SS
时间窗: Baseline to three weeks
Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers.
Change in urinary calcium oxalate supersaturation (SS)
时间窗: Baseline to 3 weeks
Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers.
次要结局
未报告次要终点