NL-OMON40146撤回3 期
Vitamin K1 to slow vascular calcification in hemodialysis patients (VitaVasK) - Vitamin K1 and vessel calcification in dialysis
RWTH Aachen0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female * 18 years of age
- •Not less than 6 months on hemodialysis
- •Cardiovascular calcification present (coronary artery volume score > 100)
- •Written consent to take part in the study
- •Life expectancy not less than 18 months
排除标准
- •Use of vitamin K
- •Known hypersensitivity against vitamin K1
- •History of thrombosis
- •Intake of vitamin K antagonists (e.g. Marcumar®) at baseline or in the 3 months prior to baseline
- •Inflammatory bowel disease
- •Short-bowel syndrome
- •Significant liver dysfunction
- •Coronary stent
- •Hemoglobin < 70 g/L
- •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 study
- •Participation in a parallel clinical trial or participation in another clinical trial within the previous 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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Vitamin K1 to slow vascular calcification in hemodialysis patientsEUCTR2010-021264-14-DERWTH Aachen University represented by the rector, himself represented by the dean of the Medical Faculty348
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Vitamin K1 to slow vascular calcification in hemodialysis patientsMedDRA version: 19.1Level: LLTClassification code 10070496Term: Hemodialysis complicationSystem Organ Class: 100000004863MedDRA version: 19.1Level: LLTClassification code 10066622Term: Chronic hemodialysisSystem Organ Class: 100000004865MedDRA version: 19.1Level: PTClassification code 10051753Term: Vascular calcificationSystem Organ Class: 10047065 - Vascular disordersEUCTR2010-021264-14-BERWTH Aachen University348
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Unknown
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