Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- PK parameters (half-life, area-under-the curve, and peak serum concentration)
研究概览
简要总结
To determine the appropriate dose and safety of a preventative dose of fondaparinux, an anticoagulant medication (blood thinner) in patients with kidney disease.
详细描述
This study will evaluate the PK of fondaparinux in patients who have renal insufficiency. Fondaparinux is cleared from the body mainly by the kidneys. Therefore in patients with kidney diseases, full doses of fondaparinux could cause bleeding problems. The correct dose of fondaparinux that should be used in patients with kidney disease is not known. The purpose of this research is to determine the PK and safety of a preventative dose (2.5mg subcutaneously every other day) of fondaparinux for patients with kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Outpatients in the Medicine and Nephrology clinics who are 18 years or older,
- •Outpatients in the Medicine and Nephrology clinics who have an estimated creatinine clearances between 20-30ml/min,
- •Outpatients in the Medicine and Nephrology clinics who are able to give consent will be included.
排除标准
- •anticoagulation therapy for thrombosis or other indication
- •pregnant or breast-feeding
- •hypersensitivity to fondaparinux
- •subjects also will be excluded if there is concern for an increased risk of bleeding which includes the following:
- •known bleeding disorder (see Section
- •Hemostatic Assessment)
- •blood transfusion in the past 3 months
- •acute ulcer disease with past 3 months
- •platelet count < 120,000 mm3
- •prolonged baseline prothrombin time (PT) or activated partial thromboplastin time (aPTT) above upper limit of normal laboratory range
- •major trauma or surgery within two weeks prior to enrollment
- •history of intracranial hemorrhage
研究组 & 干预措施
no arms/one group
干预措施: fondaparinux (Drug)
结局指标
主要结局
PK parameters (half-life, area-under-the curve, and peak serum concentration)
时间窗: after day 7 and after day 27
次要结局
- Anti-factor Xa levels and assessment for bleeding(complete blood count)(days 3, 13 and 19)