DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,800
- 试验地点
- 2
- 主要终点
- Primary Outcome of All-Cause Mortality
研究概览
简要总结
The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is:
1) Does expanded hemodialysis reduce the risk of death from any cause?
Researchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes.
Participants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux/expanded dialysis filter or a high-flux/conventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).
详细描述
Background:
Expanded hemodialysis refers to hemodialysis treatment using a newer generation of hemodialysis filters or "dialyzers" that remove large middle molecules to a greater extent than conventional "high-flux" dialyzers. This is expected to improve major health outcomes. However, despite a decade of availability and promising surrogate data from small trials and patient outcomes data from large observational studies, dialyzers capable of providing expanded hemodialysis have failed to achieve significant adoption conventional high-flux dialyzers in the absence of more definitive evidence. A large, rigorous randomized controlled trial is necessary to establish the clinical effectiveness of expanded hemodialysis compared to conventional hemodialysis with high-flux dialyzers.
Study Design:
Parallel, block randomized, controlled, open label, superiority trial comparing the clinical effects of expanded hemodialysis using Nipro Elisio HX dialyzers to conventional hemodialysis using high-flux dialyzers. The allocation ratio will vary between 1:3 or 1:1 ratio depending on their dialysis unit.
Setting:
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion requires that all the following are present:
- •Age 60 years or older; or
- •Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and
- •Receiving any form of dialysis regularly for the previous 90 days; and
- •Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and
- •A valid provincial or territorial health insurance card number.
排除标准
- •Patients are ineligible if they meet any of the following criteria:
- •Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:
- •Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or
- •Planned to receive HDF; or
- •Planned to receive nocturnal HD; or
- •Anticipated to discontinue in-centre HD in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney function, death, others); or
- •Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or
- •An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or
- •Another medical, psychosocial, or logistical reason; or
- •Enrolled in another clinical trial that explicitly prohibits concurrent participation in other clinical trials or that would substantially interfere with adherence to the DIALEX procedures (note that DIALEX otherwise permits concurrent participation in other trials); or
- •Previously enrolled in this trial; or
- •Declined participation.
结局指标
主要结局
Primary Outcome of All-Cause Mortality
时间窗: From randomization to event (death) or end of treatment (average 2.9 years follow-up), whichever occurs first
Outcome data will be collected as a result of routine patient interactions with the healthcare system and will be obtained from national and provincial data repositories (with the exceptions of routine care symptoms and ESA utilization outcomes, in participating sites), enabling health records to be analyzed in a privacy-compliant manner. These datasets have high levels of completeness and validity. The primary outcome, all-cause mortality, is captured with over 99% accuracy in our data sources.
次要结局
- Key Secondary Outcome of Cardiovascular and Infection-Related Hospitalizations(From randomization to the end of treatment (average 2.9 year follow-up))
- Receipt of a Functional Kidney Transplant(From randomization to event (functioning kidney transplant) or end of treatment (average 2.9 years follow-up), whichever comes first.)
- Key Secondary Outcome of Cardiovascular and Infection-Related Hospitalizations(From randomization to the end of treatment (average 2.9 year follow-up))
- Cardiovascular-Related Hospitalizations(From randomization to the end of treatment (average 2.9 year follow-up))
- Infection-Related Hospitalizations(From randomization to the end of treatment (average 2.9 year follow-up))
- Death from Cardiovascular Cause(From randomization to end of treatment (average 2.9 year follow-up).)
- Death from Non-cardiovascular Cause(From randomization to end of treatment (average 2.9 year follow-up).)
- Receipt of a Functional Kidney Transplant(From randomization to event (functioning kidney transplant) or end of treatment (average 2.9 years follow-up), whichever comes first.)