Pharmacokinetics and Pharmacodynamics of Apixaban in End-stage Renal Disease Patients on Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Apixaban concentration
研究概览
简要总结
This study aims to determine the effects of end-stage renal disease on the pharmacokinetics, pharmacodynamics, safety, and tolerability of apixaban. This is a single-center open-label pharmacological study. Apixaban will be prescribed at the dose of 2.5 mg twice per day for nine days. The concentration of the drug will be measured with repetitive blood tests the first and the eighth day of administration (non-dialysis days). The same blood tests will be repeated before, during, and after dialysis on dialysis days. If the study shows inadequate or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>18 years
- •end-stage renal disease on stable hemodialysis treatment (3 weekly sessions of 4 hours) for at least 6 months
- •no residual kidney function
- •non-valvular atrial fibrillation
排除标准
- •age ≥80 years
- •Body mass index (BMI)<21 or BMI>40
- •active bleeding
- •high bleeding risk (HAS BLED score >3)
- •active malignancy
- •psychiatric disorders
- •decompensated thyroid disorders
- •decompensated heart failure
- •acute myocardial infarction-cerebrovascular accident-head trauma in the last 3 months
- •previous history of venous thromboembolic disease in the last 6 months
- •previous history of coagulopathy already treated by vitamin K antagonists (VKAs) or novel oral anticoagulants
- •uncorrected rhythm or conduction disturbances
- •dual antiplatelet therapy
- •known liver disease or elevated transaminases > 2x upper limit of normal
- •Hemoglobin < 90 g/l
- •platelets < 100,000 /ml
- •known hypersensitivity to apixaban
- •treatment with a potent inhibitor or inducer of the cytochrome P450 3A4 and/or P-glycoprotein
- •absence of effective contraception where applicable
- •drug or alcohol abuse
研究组 & 干预措施
Anticoagulation
Apixaban will be prescribed at the dose of 2.5 mg twice per day for nine days.
干预措施: apixaban (Drug)
结局指标
主要结局
Apixaban concentration
时间窗: Day 8
Examine whether apixaban accumulates after an 8-day administration
次要结局
- Apixaban concentration before, during, and after hemodialysis(Before dialysis, then every hour until the end of dialysis on day 2 and day 9)
- Number of participants with treatment related adverse effects(Day 1 to 9)
研究者
Mark L. Lipman
Associate Professor of Medicine
Jewish General Hospital