A Clinical Study With the Carry Life® UF System in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Triomed AB
- 入组人数
- 28
- 试验地点
- 11
- 主要终点
- Ultrafiltration volume
研究概览
简要总结
The Carry Life UF system performs peritoneal ultrafiltration by adding glucose to the low glucose strength (1.36%) peritoneal dialysis fluid which has been instilled into the peritoneal cavity prior to the connection of the device. By maintaining a stable glucose concentration in the intraperitoneal fluid during the 5-hour treatment, the ultrafiltration can be increased compared to a standard CAPD dwell.
详细描述
A study of the peritoneal ultrafiltration achieved with Carry Life® UF system compared to standard peritoneal dialysis (PD) therapy, in CAPD patients.
The study consists of the following five (5) phases:
- Inclusion phase.
- In-clinic treatment phase for dose determination and safety evaluation.
- Randomization phase.
- Transition to home treatment phase.
- Home treatment phase for efficacy and safety evaluation.
The in-clinic phase consists of one 2.27% Peritoneal equilibrium test (PET) and two Carry Life® UF treatments; one with a 11 g/h glucose dose and one with a 15 g/h glucose dose. The Carry Life® UF treatments will be used for a safety evaluation and based on the UF volumes achieved with the Carry Life® UF treatments, the Carry Life® UF glucose dose for the home treatment phase will be determined. A 24-h urine sample will be collected before the first visit for determination of residual renal function.
After completion of the in-clinic treatment phase, subjects will be randomized to start the home treatment phase either with the control treatment arm or with the Carry Life® UF treatment arm. Subjects in the control arm will continue their standard CAPD treatment as prescribed. In the Carry Life® UF arm, for three days of the week one 2.27% glucose CAPD dwell per day will be replaced by a Carry Life® UF treatment. For the remaining four days of the week, one 2.27% glucose CAPD dwell will be replaced with a 1.36% glucose CAPD dwell.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Subjects with ESKD treated with PD for at least three (3) months.
- •A PD prescription of 2-4 CAPD dwells/day unchanged for a minimum of two (2) weeks, with at least one 1.5-2L, 2.27% glucose day dwell daily.
- •Subjects must be able to tolerate a 2 L PD fill volume for the PET.
- •Subjects using the Baxter PD system with a MiniCap transfer set.
- •In the opinion of the Investigator, the subject has the capacity to learn how to use the Carry Life® UF system or has a caregiver who can do so.
- •Obtained written consent to participate in the study.
排除标准
- •A PD prescription including a regular 3.86% glucose day dwell.
- •An episode of peritonitis within the last three (3) months.
- •Serum potassium > 6 mmol/l within the last three (3) months.
- •Serum urea > 35 mmol/l within the last three (3) months.
- •Clinical signs of dehydration.
- •Systolic blood pressure < 100 mmHg within the last month.
- •Known diagnosis of clinically significant aortic stenosis.
- •Clinical condition of unstable diabetes.
- •Subjects with a life expectancy of < six (6) months.
- •Evidence of any other diseases or medical conditions that may interfere with the planned treatment or affect participant compliance.
- •Participation in clinical trials, interfering with the present study, within the previous month.
- •Anticipated living donor kidney transplantation within six (6) months of screening.
- •Pregnant, breastfeeding, or women of childbearing potential who are not using an effective method of contraception (hormonal contraceptives or barrier contraceptive methods).
研究组 & 干预措施
Control CAPD treatment
The subjects will receive their standard CAPD treatment.
干预措施: 2.27% glucose peritoneal dialysis dwell (Drug)
Carry Life UF
Three days per week, the subject will replace a 2.27% glucose dwell with the Carry Life® UF treatment. The remaining four days of the week, one 2.27% glucose dwell will be replaced by a 1.36% glucose dwell.
干预措施: Carry Life UF (Device)
结局指标
主要结局
Ultrafiltration volume
时间窗: 8 weeks
The UF volume is the difference between the drained fluid volume and the administered fluid volume. The average of two treatments per arm during the home phase of the study.
次要结局
- Adverse event rates(8 weeks)
- Peritoneal sodium removal(8 weeks)
- Glucose UF efficiency(8 weeks)
- Peak dialysate glucose concentration(2 weeks)