A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 25
- 主要终点
- Mean Standardized Weekly Kt/V (Efficacy)
研究概览
简要总结
The purpose of this study is to determine non-inferiority in safety and efficacy when Quanta SC+ is used in the self-care home environment compared to a hemodialysis facility.
详细描述
This clinical trial is being conducted to evaluate the Quanta SC+ hemodialysis System for home use by patients with established kidney failure. A dialysis prescription of 3 sessions per week, 4 hours per session, or facility standard will be provided during the in-clinic training period, followed by the home period with a dialysis prescription of 4 sessions per week, 3.5 hours per session.
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
- •Provision of a written informed consent form signed by the participant
- •Age between 18 and 80 years at time of enrollment
- •A care partner must be available for training on SC+ and to be present in the home during all home hemodialysis sessions
- •Participants should be either receiving regular, facility-based hemodialysis therapy for at least 90 days, or in the case of peritoneal patients transitioning to hemodialysis, at least 90 days, or performing home dialysis (with any frequency) for at least 90 days and willing to return to facility for purpose of study, and should be clinically stable and deemed suitable for home dialysis in the opinion of the principal investigator
- •Willing to accept a dialysis prescription of 3 sessions per week, 4 hours each session or facility standard during in-clinic visits; 4 sessions, 3.5 hours each session during in-home sessions
- •In the opinion of the Investigator, participant has 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
- •Home environment is adequate to ensure that appropriate electrical connections and water supply necessary for the use and storage of the device as assessed by Quanta prior to subject C1 visit. Also ensure that cellular signal and/or WIFI capacity is adequate.
- •Participant or care partner are capable of understanding the nature of procedures and requirements of the study protocol and of home-based hemodialysis, and are willing and capable of complying with protocol and returning to treatment center as stated in protocol
- •Participant or care partner are capable of being trained to use the machine and troubleshoot should an alarm situation occur
- •In the opinion of the treating physician, the subject is able to participate in the trial in terms of social factors and personal functioning
- •Acceptable physical ability of the participant and/or care partner to perform the hemodialysis treatment at home
- •Financial coverage for treatment costs by Medicare, Medicaid, private insurance, or other arrangement acceptable to participant
排除标准
- •Pregnant or trying to become pregnant (women of childbearing potential must use medically accepted contraceptive measures)
- •Predicted life expectancy of less than 12 months from first study procedure
- •Major cardiovascular adverse event in the 3 months prior to screening
- •Fluid overload due to intractable ascites secondary to liver cirrhosis
- •Uncontrolled or unstable blood pressure (systolic BP outside the range 90 to 180 mmHg)
- •Unstable coronary artery disease
- •New York Class III or IV heart failure, or ejection fraction less than 30%
- •Participation in other clinical studies that may interfere with the current protocol
- •Known problems with coagulation
- •Active, life-threatening, rheumatologic disease.
- •Hematocrit less than 28% at enrollment
- •Hemoglobin less than 9 g/dL at enrollment
- •Suffering from active severe infection
- •Seroreactive for hepatitis B surface antigen
- •Suffering from active malignancy with expected deteriorating course within 6-12 months
- •History of severe reactions to dialyzer membrane material
- •Expected to receive an organ transplant during the course of the study
- •Have dementia or inability to understand procedures
- •Lack an ability for self-care
- •Are non-adherent to their current dialysis treatments
- •Experience intra-dialytic hypotension defined as a decrease in systolic blood pressure of greater than or equal to 20 mmHg or a decrease in mean arterial pressure of greater than or equal to 10 mmHg provided that the decrease is associated with clinical events (symptoms) and the need for an intervention (ultrafiltration turned off, bolus of fluid) in 3 of 5 previous treatments
- •Is intolerant to heparin
- •Considered in the investigator's opinion to be clinically unstable for any other reason
- •Undergoing outpatient dialysis for the treatment of acute kidney injury (AKI)
结局指标
主要结局
Mean Standardized Weekly Kt/V (Efficacy)
时间窗: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
The primary effectiveness endpoint was the delivery of a mean standardized weekly Kt/V of greater than or equal to 2.1 in both the clinic phase and the home phase. The weekly standard Kt/V is used to assess dialysis effectiveness by taking into account the clearance provided by individual treatments and the number of times per week the participant treated. The weekly standardized Kt/V is calculated using K (clearance of urea), T (treatment time), and V (urea distribution volume). Current practice guidelines include achieving a minimum result of 2.1 with a target of achieving 2.3, with higher values representing better outcomes. A theoretical range for the minimum and maximum standardized weekly Kt/V does not exist.
Adverse Event Rate
时间窗: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Adverse event rate: the number of adverse events per 100 treatments that occurred during the study, as defined by: * Serious adverse event (SAE) * Allergic reaction: type A, anaphylactoid or type B dialyzer reactions to dialyzer, blood tubing, or chemical disinfectant. * Blood loss: resulting in hemodynamic compromise that led to death, transfusion, or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. * Hemolytic reaction: due to disinfectant exposure, dialysate temperature, mechanical failure, or other device related causes. * Infection: related to hemodialysis catheter, its tunnel or exit site, arteriovenous fistula (AVF), or arteriovenous graft (AVG). * Intradialytic event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure. * Vascular access complication * Pyrogenic reaction
次要结局
- Rate of Serious Adverse Events (SAEs) Per 100 Treatments.(4-8 weeks in the clinic training phase and 8 weeks during the home phase.)