EUCTR2011-003081-32-NL进行中（未招募）不适用
DABIRENAL STUDY A study to investigate the pharmacokinetics and effects of Dabigatran in patients with stable severe chronic kidney disease - lumc-30706-IV
eiden University Medical Center0 个研究点开始时间: 2012年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age: 18 years and older
- •Able and willing to give informed consent
- •Impaired renal function defined as a stable MDRD and/or creatinine clearance
- •estimated using urinary excretion between 15-30 ml/min over the last 3 months
- •before study participation
- •The single use of either aspirin or Vitamin K-antagonists
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-Instable renal function (i.e. an increase in serum creatinine > 20% in the last three months)
- •-Patients treated with two or more platelet aggregation inhibitors
- •-Use of or indication for therapeutic (low molecular weight) heparin
- •-Patients with mechanic heart valves
- •-Any known bleeding disorder or tendency
- •- Uncontrolled hypertension (systolic >180mmHg or diastolic >100mmHg)
- •- Diabetes mellitus with active retinopathy
- •- Pre-menopausal women not willing to use appropriate contraception (e.g. oral anti conceptive
- •drugs or intrauterine devices)
- •- Recent cerebral bleeding or cranio-cerebral trauma (within the last six months)
- •- Moderate to severe liver impairment (ALT >2 ULN)
- •- Gastrointestinal surgery within the last three months (except for appendectomy,
- •cholecystectomy or herniotomy)
- •- Use of P-glycoprotein inhibitors
- •- Relevant acute infections (e.g. acute pneumonia)
- •- History of allergy or hypersensitivity (including drug allergies) deemed relevant by the
- •investigator
- •- Planned diagnostic or therapeutic procedures with potential for uncontrollable bleeding within
- •30 days before, during or after the trial
- •- Indication of past of present use of drugs or abuse
- •- Past history of alcoholism with clinical sequelae or present use of alcohol >3U daily (male)
- •or 2U daily (female)
- •- Participation in another drug trial
研究者
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