EUCTR2010-021264-14-BE进行中（未招募）1 期
Vitamin K1 to slow vascular calcification in hemodialysis patients.Multicenter, multinational, randomized controlled clinical trial - VitaVasK
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 348
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
- •- Male or female = 18 years of age
- •- Not less than 6 months on hemodialysis
- •- Calcification score > 100
- •- Written consent to take part in the study
- •- Expectation of life not less than 18 months
- •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 114
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 234
排除标准
- •- Known hypersensitivity against vitamin K1
- •- Intake of Vitamin K
- •- History of thrombosis (except shunt occlusion)
- •- Intake of Vitamin K antagonists (e.g. Marcumar®)
- •- Inflammatory bowel disease
- •- tumor disease
- •- Short-bowel-syndrome
- •- Liver dysfunction
- •- anemia (Hb < 70 g/l)
- •- More than one stent in one coronary artery plus one or more stents in an additional artery
- •- Pulse > 100/min (resting heart rate)
- •- Women who are pregnant or breastfeeding
- •- Women without sufficient contraception
- •- Alcohol or drug abuse
- •- Mental condition rendering the subject unable to understand the
- •nature, scope, and possible consequences of the study
- •- Subject unlikely to comply with protocol, e.g. uncooperative attitude,inability to return for follow-up-visits, and unlikelihood of completing the
- •- Participation in a parallel clinical trial or participation in another
- •clinical trial within the last 3 months
- •- Subjects who are in any state of dependency to the sponsor or the
- •investigators
- •- Employees of the sponsor or the investigators
- •- Subjects who have been committed to an institution by legal or
- •regulatory order
研究者
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