EUCTR2018-003232-80-FR进行中(未招募)1 期
RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine : A Randomized, Double-blind, Placebo-controlled, Cross-over Trial - RENACTIF
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
- •Adult subjects of both sexes aged 18 years and over
- •Affiliated subjects or beneficiaries of a social security scheme
- •Hemodialysis patients regardless of the etiology of their renal insufficiency for more than three months on a cycle of three sessions per week
- •Hemodialysis patients at least four hours per dialysis session
- •Patients with a weight of more than 40kg
- •Subjects capable of giving informed consent, agreeing to participate in the study and having signed a consent
- •Patient able to understand a written questionnaire
- •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
- •Pregnant or lactating women
- •Persons deprived of their liberty or hospitalized without consent
- •Majors under legal protection or unable to express their consent Possibility of recovery of renal function
- •Chronic progressive infection that may affect their thrombotic risk: progressive neoplasia, anticoagulant treatment prescribed for less than 1 month
- •Patients with a weight under 40 kg
- •Patient not able to express his consent
- •Patient taking AVK-type oral anticoagulants outside anticoagulation during the session.
- •Patient with a known allergy to the active molecule or an excipient
研究者
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