2025-524093-41-00招募中2 期
INCREDIBLE: INCREmental DIalysis and diet for a Better Life Experience; Clinical relevance of an “add-on” Ketosteril supplementation on incremental haemodialysis period in incident haemodialysis patients. An exploratory randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
To evaluate the efficacy of the addition of Ketosteril to the usual nutritional plan to patients who start incremental haemodialysis with respect to the end-point duration of the incremental haemodialysis period
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 18 years or older)
- •Able and accepting to give informed consent
- •Starting incremental Haemodialysis in the Centre Hospitalier Le Mans
排除标准
- •Denying informed consent
- •Previous enrolment in a randomized study using Ketosteril
- •Currently enrolled in another interventional clinical trial
- •Protected by law (patient under guardianship, minor, prisoner, pregnant or breastfeeding woman, …)
- •Acute kidney injury (AKI)
- •Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months
- •Cognitive impairment severe enough to limit understanding and acceptance of the study
- •Impossibility to regain kidney function (bilateral nephrectomy, documented irreversible complete destruction of the kidney tissue)
- •Patient with genetic disease affecting amino acid metabolism
- •Hypercalcemia defined as calcemia beyond the upper limit of normality according to the laboratory where the test is performed and persisting for at least one month
- •Hypersensitivity to the active substances or to any of the excipients of Ketosteril
- •Non-compliance to dialysis prescription
研究者
Clinical research project manager
Scientific
Centre Hospitalier Le Mans
研究点 (1)
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