NCT05827588已完成不适用
A Prospective, Single-arm Study to Evaluate the Feasibility of Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) in Subjects With End-Stage Kidney Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proportion of completed therapies
研究概览
简要总结
The goal of this late feasibility clinical trial is to evaluate the safety and effectiveness of the Automated Wearable Artificial Kidney (AWAK) peritoneal dialysis (PD) device in subjects with end-stage kidney disease. The main questions it aims to answer are:
- the success of AWAK PD therapies when used in a home-setting
- the safety and effectiveness of the AWAK PD system
Participants will:
- be titrated to find a suitable AWAK PD prescription
- be trained on how to use the AWAK PD system independently
- use the AWAK PD system at home for at least 7 days
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the study.
- •Male or female ≥22 years of age.
- •Treated with PD for at least 3 months before Screening.
- •Has weekly Kt/Vurea (renal + peritoneal) ≥1.7
- •No acute peritonitis, catheter infection, exit site, or subcutaneous tunnel infection within 3 months before Screening.
排除标准
- •Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good investigation candidate
- •Recent (within the previous 6 months) history of major cardiovascular events (e.g., stroke, acute myocardial infarction).
- •Diagnosed with New York Heart Association (NYHA) Class III or Class IV heart failure.
- •Poorly controlled diabetes mellitus as defined by hemoglobin A1c >9.0% during Screening
- •Subject has a current abdominal hernia.
- •Subject has an active infection requiring systemic antibiotics or antifungal therapy.
- •Active infection of hepatitis B and C, or HIV infection at any time.
结局指标
主要结局
Proportion of completed therapies
时间窗: 7 days
次要结局
- Incidence of peritonitis related to the use of AWAK PD(30 days)
- Proportion of subjects maintaining body weight within ±5% of the subject's target weight(7 days)
- Change in serum levels of markers of uremia (urea and creatinine)(7 days)
- Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events(7 days)
- Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges(7 days)
- Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire(30 days)
研究者
研究点 (1)
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