EUCTR2019-004906-88-NL进行中（未招募）1 期
Placebo-controlled double-blind randomized controlled trial investigating vitamin K supplementation on vascular calcification propensity in vitamin K deficient renal transplant recipients - NTx-vitK
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
- 40
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1. Age =18 years
- •2. Male and female renal transplant recipients
- •3. Participant of TransplantLines
- •4. Vitamin K deficient; dp-ucMGP >500 pmol/L
- •5. eGFR > 20 ml/min/1.73m2
- •6. Signed informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1. Treatment with vitamin K antagonists or direct oral anticoagulants (DOAC)
- •2. Atrial fibrillation or other heart rhythm disorders causing an unreliable PWV measurement
- •3. Known coagulopathy
- •4. Active malignancy; exception treated basal cell or squamous cell carcinoma
- •5. Current or planned pregnancy or lactation
- •6. Known intestinal malabsorption
研究者
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