Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 15
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
This prospective multi-center, open-label, single-arm study intends to gather and evaluate safety data for the nocturnal use of the HemoCare™ Hemodialysis System.
详细描述
The HemoCare™ Hemodialysis System has been evaluated in previous clinical trials and is designed to perform hemodialysis (HD) in a clinic setting, in a self-care setting, or in a home environment for conventional HD, short daily HD or extended-duration HD therapy during the daytime or at night dependent on the users' lifestyle or work schedule. This multi-center, open-label, single-arm cross-over study is designed specifically to gather and evaluate safety data for the use of the HemoCare™ Hemodialysis System (including labeling and training tools) during home nocturnal (during sleeping hours based on the patient schedule) use. Nocturnal HD therapy was chosen as a treatment in this study because of the clinical and humanistic benefits associated with it. In addition, its risk profile, especially when performed in a home setting, may be greater than either existing conventional or short daily HD therapies. In this regard, establishing an acceptable safety profile for home nocturnal HD therapy should be sufficient evidence to support conventional and short daily HD home therapies with HemoCare™ Hemodialysis System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Have been diagnosed with ESRD and are ≥ 18 years of age.
- •Are in stable clinical condition as judged by the treating physician, and confirmed by medical history, physical exam, and laboratory testing for 30 days prior to enrollment.
- •Have been receiving HD for at least 30 days prior to study enrollment, are expected to survive for at least 12 months and in the opinion of the Investigator are stable to start in the trial.
- •Have been dialyzing in a supervised medical facility or at home for ≥ 3 times per week.
- •Are willing to comply with the study requirements for training and therapy with HemoCare™ Hemodialysis System for the entire study treatment period.
- •Understand English and can provide written informed consent (both the subject and care partner).
- •Are judged by the Investigator to be suitable for Home HD (the Investigator deems that with appropriate training, the subject and/or care partner will be able to successfully cannulate and/or manage the vascular access during the Unassisted Home Evaluable Period).
- •Have a stable functioning vascular access as judged by the treating physician.
- •Have a weekly stdKt/Vurea ≥ 2.0, an equivalent URR ≥ 0.65, rated Kt/Vurea ≥ 1.0 on one occasion within 30 days prior to enrollment.
排除标准
- •Are pre-scheduled for a living donor transplant within the next 6 months.
- •Have a contraindication to heparin.
- •Are currently participating in another interventional study.
- •Have experienced an acute myocardial infarction with hospitalization, coronary artery bypass surgery, or acute coronary ischemia requiring angioplasty or stent insertion within 90 days of screening.
- •Have ongoing NYHA Class III or IV heart failure.
- •Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures.
- •Have ongoing sepsis or bacteremia and currently require IV antibiotics.
- •Have an allergy to polysulfone dialyzer.
- •Current self-reported pregnancy, actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study.
- •Subject with fluid overload due to intractable ascites secondary to liver cirrhosis
结局指标
主要结局
Primary Safety Endpoint
时间窗: 31 weeks
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Primary Performance Endpoint
时间窗: 31 weeks
Weekly stdKt/Urea was calculated from pre- and post-dialysis urea levels during each evaluable period. Blood samples were obtained every two weeks during each Evaluable Period. For the primary performance endpoint, 'success' is defined as a subject who has all stdKt/Vurea measures in an evaluable period greater than or equal to 2.0.
次要结局
- The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.(31 weeks)
- Weight Change and Fluid Removed Comparison Between Evaluable Periods(31 weeks)
- The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)(31 weeks)
- The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels(31 weeks)