A Multicentre, Open-label, Prospective, Randomized Study to Explore the Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line - Hemodiafiltration (Study MoTHER HDx)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Cardiovascular morbility
研究概览
简要总结
study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.
Approximately 700 patients will be included.
详细描述
This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.
Stable incident hemodialysis patients from hemodialysis in-hospital units and related satellite centers in Spain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •End stage Renal Disease (ESRD) patients
- •Age> 18 years old
- •HD therapy three times per week for 3 months at least and a maximum of 24 months.
排除标准
- •No informed consent provided
- •Synthetic membrane allergy
- •Pregnant, breastfeeding, or planning to become pregnant
- •Active systemic diseases: liver cirrhosis, malignancy prior to enrollment (except basal cell skin or similar) and / or immunosuppressive treatment in the 3 months before the recruitment.
- •Scheduled for living-donor transplantation within the study period
- •Patients with a significant residual renal function (defined as Urea clearance >2,5 ml/min.
- •Currently participating in another interventional clinical study or has participated in another interventional clinical study in the last 3 months that may interfere with this study.
结局指标
主要结局
Cardiovascular morbility
时间窗: every 3 months
Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis.
次要结局
未报告次要终点