NCT00490113撤回2 期
Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Urinary Excretion of Oxalate at Highest Dose
研究概览
简要总结
To determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal oxalate excretion (but who have had kidney stones), and in subjects who have primary hyperoxaluria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Adults > 18 years
- •History of stone formation
- •Good Renal function
- •Normal urinary excretion of stone-promoting chemicals(Ca, uric acid, oxalate, citrate), except for subjects with hyperoxaluria for Study
排除标准
- •Pregnancy
- •Hyperparathyroidism
- •Enteric hyperoxaluria.
- •Obstructive uropathy
- •Infection (struvite) stones
- •Severe dietary Ca++ restriction or deficiency
- •Recent significant cardio-vascular events
研究组 & 干预措施
1
Experimental
干预措施: Pyridoxamine (Drug)
结局指标
主要结局
Urinary Excretion of Oxalate at Highest Dose
时间窗: 4 Weeks
次要结局
- Change in Urinary Supersaturation(4 Weeks)
研究者
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