An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient
研究概览
简要总结
Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo."
详细描述
This is a prospective, sequential, multi-center, open-label study with subjects on thrice-weekly (in-center) hemodialysis (HD). After a Screening Period, there will be 12 hemodialysis treatments on the Optiflux dialyzer (Optiflux Period), followed by 38 HD treatments on the dialyzer with Endexo (Endexo Period), and then a Follow-up Visit. The study population will consist of End-Stage Renal Disease ESRD subjects who are a minimum of 22 years of age. The primary objective of the study is to collect data on the performance of the dialyzer with Endexo when used to perform hemodialysis (HD) in End-Stage Renal Disease (ESRD) subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be an adult, older than 22 years of age.
- •Has been prescribed in-center thrice-weekly HD continuously for at least 180 days prior to the date of signed informed consent
- •Has been prescribed the Optiflux F160NR dialyzer continuously for at least 30 days prior to the date of signed informed consent
- •Has a prescribed HD treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours)
- •Has been on heparin anticoagulation for dialysis and has had no change in heparin prescription within 14 days prior to the date of signed informed consent
- •Has a most recent single pool Kt/V (spKt/V) ≥1.2 within 45 days prior to the date of a signed informed consent
- •Has a most recent hemoglobin ≥9 g/dL within 45 days prior to the date of a signed informed consent
- •Has a most recent platelet count ≥100,000/mm3 within 45 days prior to the date of a signed informed consent
- •A female of childbearing potential must have a negative serum pregnancy test at the time of screening and agree to use an acceptable method of contraception during the study
排除标准
- •Use of citric acid concentrate (such as Citrasate®) at the time of signed informed consent
- •Known allergic reactions to Endexo
- •Hospitalization within 30 days prior to the date of signed informed consent
- •Presence of active malignancy, congestive heart failure New York Heart Association (NYHA) Class III or IV, or liver cirrhosis
- •Are receiving or have received chemotherapy / radiation therapy / plasmapheresis therapy within 90 days prior to the date of signed informed consent
- •Are receiving antibiotics or have used antibiotics within 14 days prior to the date of signed informed consent
- •Are currently enrolled in or have completed any other investigational product study within 30 days prior to the date of signed informed consent
- •Has a life expectancy of less than 1 year
结局指标
主要结局
Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient
时间窗: 15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study
Ultrafiltration coefficient (Kuf) is the ratio of ultrafiltration rate in ml/hr to the Transmembrane pressure in mmHg. Both the Ultrafiltration rate and the transmembrane pressure readings are collected from the machine.
次要结局
- The Number of Any Adverse Events(Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.)
- Removal of Albumin(Pre- and Post- HD at Visits 1/week 1, 13/week 5)
- The Number of Any Device-related Adverse Events(Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.)
- Removal of Urea(At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16)
- Removal of Beta-2-microglobulin(Pre- and Post- HD at Visits 1/week 1, 13/week 5)