Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Participants With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 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 safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are between 18 and 80 years of age and Care Partner is at least 18 years of age at the time of signing consent.
- •Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Screening Period
- •Have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min prior to the end of Screening
- •Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period.
排除标准
- •Hgb level of < 9 g/dL at Screening
- •Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as:
- •Persistent pre-dialysis sitting SBP < 100 mmHg despite medical therapy,
- •Nadir intradialytic Systolic Blood Pressure (SBP) < 90 mmHg, if Subject's pre-HD SBP < 160 mmHg
- •Nadir intradialytic SBP < 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg
- •Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study
- •Participant had an average ultrafiltration rate > 13 mL/kg/hour during the last 2 weeks prior to Screening, per medical records.
- •Had a significant cardiovascular adverse event within the last 90 days prior to Screening.
研究组 & 干预措施
Professional Care and At Home
Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting
干预措施: Moda-flx Hemodialysis System™ (Device)
结局指标
主要结局
Weekly Standardized Dialysis Adequacy
时间窗: Up to 10 weeks per period
Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings
Adverse Event (AE) Rate
时间窗: Up to 10 weeks per period
The adverse event (AE) rate: defined as the number of Study Emergent AEs per 100 dialysis treatments occurring in the At Home period of the study, compared with those occurring during the Professional Care period.
次要结局
- Goal Ultrafiltration Volume(Up to 10 weeks per period)
- Study Emergent Pre-Specified Adverse Events(Up to 10 weeks per period)