A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the Tablo Hemodialysis System In-Center and In-Home by Subjects With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Weekly Standardized Dialysis Adequacy
研究概览
简要总结
The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
- •Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
排除标准
- •Life expectancy less than 12 months from first study procedure.
- •Subject has had a recent major cardiovascular adverse event within the last 3 months.
- •Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
- •Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
- •Subject has uncontrolled blood pressure.
- •Subject is intolerant to heparin.
- •Subject is seroreactive for Hepatitis B Surface Antigen.
- •Subject has an active, life-threatening, rheumatologic disease.
- •Subject has a history of adverse reactions to dialyzer membrane material.
- •Subject is expected to receive an organ transplant during the course of the study.
- •Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
结局指标
主要结局
Weekly Standardized Dialysis Adequacy
时间窗: 8 weeks per period
Weekly standardized dialysis adequacy (stdKt/V) was measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.
Incidence of Pre-Specified Adverse Events
时间窗: 8 weeks per period
All adverse events (AEs) observed in the trial were reviewed by an independent Clinical Events Committee (CEC). AEs adjudicated into the following pre-specified categories were included in the outcome measure: 1. Serious Adverse Event 2. Allergic Reaction: to dialyzer, blood tubing or chemical disinfectant. 3. Blood Loss: that leads to death, transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. 4. Hemolytic Reaction: due to disinfectant exposure, dialysate temperature, mechanical failure or other device related causes. 5. Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft. 6. Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure. 7. Vascular Access Complications 8. Pyrogenic Reaction
次要结局
- Ultrafiltration Rate Success(8 weeks per period)