NCT03345316已完成3 期
Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ratio of Cin to Ccr measuring at the same time
研究概览
简要总结
The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney disease patients requiring exact evaluation of kidney function
- •eGFR: >=30 and <=89 mL/min/1.73m^2
排除标准
- •Edema on the day before start of study treatment
- •Oliguria on the day before start of study treatment
- •Dehydration on the day before start of study treatment
- •Infection or inflammatory disease before administration
- •History of epilepsy or organic brain disorder
- •History of, clinically significant cardiac, hematologic, hepatic and pancreatic disease
研究组 & 干预措施
FFI-1010
Experimental
干预措施: FFI-1010 (Drug)
结局指标
主要结局
Ratio of Cin to Ccr measuring at the same time
时间窗: 120 minutes
Demonstrating usability of inulin clearance by comparison between inulin clearance and creatinine clearance at the same time after the start of FFI-1010 administration
次要结局
未报告次要终点
研究者
研究点 (1)
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