NCT03177031已完成不适用
A Randomised, Open-label, Parallel Group, Multi-centre Controlled Study to Evaluate the Clinical Performance and Safety of Stay Safe Link® Compared With Stay Safe® in Patients With End-stage Kidney Disease on Continuous Ambulatory Peritoneal Dialysis
Penang Hospital, Malaysia2 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2017年6月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 472
- 试验地点
- 2
- 主要终点
- Peritonitis Rate of Stay Safe Link system
研究概览
简要总结
This post-marketing study is undertaken to compare the clinical effectiveness and safety of two continuous ambulatory peritoneal dialysis produced by Fresenius Medical Care (FMC), i.e. Stay Safe® (STS) that is produced by a plant in Germany and Stay Safe Link® (SSL) that is produced in Malaysia. The study is an open labelled, randomised controlled trial where 434 patients in total will be randomised to either STS or SSL in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or above
- •End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
- •Written informed consent
排除标准
- •Requirement for 2.5L exchanges
- •Requirement for Stay Safe Balance®
- •PD-related infection (peritonitis, exit site or tunnel tract infection) in the preceding 8 weeks or during conversion
- •Malfunctioning of PD catheter
- •Planned transfer to automated peritoneal dialysis, haemodialysis or transplant within 90 days
- •Any condition that compromises the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity, such as documented loss of peritoneal function
- •History of active alcohol or substance abuse in the previous 6 months
- •Other medical condition which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
研究组 & 干预措施
Stay Safe (STS)
Active Comparator
CAPD system produced by Fresenius Medical Care in Germany
干预措施: Stay Safe (STS) (Device)
Stay Safe Link (SSL)
Experimental
CAPD system produced by Fresenius Medical Care in Malaysia
干预措施: Stay Safe Link (SSL) (Device)
结局指标
主要结局
Peritonitis Rate of Stay Safe Link system
时间窗: 1 year
次要结局
- Safety Assessment of the PD system(1 year)
- Ultrafiltration volume(1 year)
- Dialysis dose delivered(1 year)
- Product deficiencies of the PD system(1 year)
研究者
研究点 (2)
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