Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration - Exploratory, Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in cardiovascular surrogate marker
研究概览
简要总结
Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodiafiltration (HDF). The present study addresses to compare clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and HDF.
详细描述
While conventional hemodialysis (HD) modality effectively removes small-sized molecules, performance with middle-sized and protein-bound molecules is not well established. With increasing perception on importance of middle molecule removal, on-line hemodiafiltration (HDF) is getting more attention from healthcare professionals. However, HDF has not been widely used in Korea due to its technical burden and limited public funding issue.
Novel medium cut-off (MCO) dialyzer, Theranova, is available in Korea, which showed superior performance on middle molecule removal to conventional HD and HDF from the previous study. This new dialyzer can be a good alternative option replacing conventional HD or even HDF with its benefits. However, current data available on the MCP dialyzer has certain limitations such as small sample size, no Asian subject included, limited types of biomarkers, and no clinical outcomes (particularly cardiovascular diseases) included.
With this respect, performance comparison of MCO dialyzer with HDF in terms of clinical outcomes, including cardiovascular endpoint would fill the exiting data gap, which is absolutely important to make a clinical decision on dialysis modality.
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
- •18 years old and older
- •Hemodialysis more than 3 months because of end-stage renal disease
- •Consent to the study protocol
排除标准
- •Already receiving online hemodiafiltration before study enrollment
- •Dialysis schedule other than three times per week (e.g., once per week)
- •Receiving concurrent peritoneal dialysis
- •Having a plan to receive kidney transplantation within 1 year
- •Having multiple myeloma or monoclonal gammopathy
- •Having advanced or active malignancy
- •Having a plan to be pregnant or being pregnant / breast-feeding or not having a plan to use contraception
- •Participating in other clinical trials
研究组 & 干预措施
Study group
Extended HD with MCO dialyzer
干预措施: Theranova (Device)
Control group
Online hemodiafiltration
干预措施: Online hemodiafiltration (Device)
结局指标
主要结局
Change in cardiovascular surrogate marker
时间窗: 0, 6, 12 months
Brachial-ankle pulse wave velocity (m/s)
次要结局
- Change in cardiac surrogate marker #2(0, 6, 12 months)
- Change in cardiovascular biomarkers #1(0, 6, 12 months)
- Change in cardiovascular biomarkers #2(0, 6, 12 months)
- Change in cardiovascular biomarkers #3(0, 6, 12 months)
- Change in cardiovascular biomarkers #4(0, 6, 12 months)
- Change in cardiovascular biomarkers #5(0, 6, 12 months)
- Change in cardiovascular biomarkers #6(0, 6, 12 months)
- Change in cardiac surrogate marker #1(0, 6, 12 months)
- Patient-reported outcomes #1(0, 6, 12 months)
- Patient-reported outcomes #2(0, 6, 12 months)
- Patient-reported outcomes #3(0, 6, 12 months)
研究者
Kwon wook Joo
Professor
Seoul National University Hospital