NCT04006093已完成1 期
Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Apixaban maximum plasma concentration
研究概览
简要总结
The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.
详细描述
Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with 21<BMI<40
- •French participant
- •Participant able to consent
- •Participant with social insurance
- •Participant on peritoneal dialysis for at least 3 months with end-stage renal disease treated
排除标准
- •Participant with hypersensibility reactions to apixaban
- •Participant with a history of major bleeding
- •Participant already on anticoagulant
- •Participant on non-stearoid anti-inflammatory at anti-inflammatory dosage > 300 mg
- •Participant on potent inhibitors of CYP 3A4 and P-gp
- •Participant on inducers of CYP3A4 and P-sp
- •Participant with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- •Participant receiving or having received antibiotic treatment within 14 days prior to study
- •Pregnant or lactating women
- •Participant with known hypersensitivity reactions to icodextrin
- •Participant not supporting an intraperitoneal volume of 2 liters (only participant with peritoneal dialysis)
- •Participant with "Normal renal function" with glomerular filtration rate < 90 ml/min
研究组 & 干预措施
participants with normal renal function
Experimental
干预措施: Apixaban Oral (Drug)
participants with end-stage renal disease
Experimental
干预措施: Apixaban Oral (Drug)
结局指标
主要结局
Apixaban maximum plasma concentration
时间窗: Day 3
Measurement of apixaban plasma concentrations at different times.
Apixaban area Under the curve
时间窗: Day 3
Measurement of apixaban plasma concentrations at different times.
次要结局
- TP activity(Hour 0, Hour 3, Hour 9 and Hour 72)
- anti-Xa activity(Hour 0, Hour 3, Hour 9 and Hour 72)
- Apixaban urinary elimination(Day 3)
- TCA activity(Hour 0, Hour 3, Hour 9 and Hour 72)
- Apixaban maximum peritoneal concentration(day 3)
研究者
研究点 (1)
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