Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Daily ultrafiltration volume
研究概览
简要总结
Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
- •Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
- •Hemoglobin level ≥ 9g/dL;
- •Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
- •To understand and sign an informed consent form.
排除标准
- •History of alcohol or drug abuse in the last six months before selection for the study;
- •Androgen therapy in the last six months before selection;
- •Active infections;
- •History of congestive heart failure stage III and IV New York Heart Association (NYHA);
- •History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
- •Clinically relevant cardiac arrhythmia;
- •Clinically relevant abnormalities of functional hepatic tests;
- •Therapy with L-carnitine or its derivatives in the last three months before selection;
- •Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
- •Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
- •Participation in another clinical study within the past month;
- •Known allergic reactions to L-carnitine or xylitol.
研究组 & 干预措施
Experimental peritoneal dialysis solution IPX15
Patients will receive treatment with the experimental solution for nocturnal (long-dwell) exchange. For daily (short-dwell) exchanges, all patients will continue the 1 to 3 bags of glucose peritoneal dialysis solution as for their pre-randomization prescription.
干预措施: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine (Drug)
Experimental peritoneal dialysis solution IPX07
Patients will receive 1 to 3 daily (short-dwell) exchanges with the experimental solution (the number of exchanges will be based on their pre-randomization prescription). All patients will receive icodextrin for nocturnal (long-dwell) exchange.
干预措施: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine (Drug)
结局指标
主要结局
Daily ultrafiltration volume
时间窗: 28 days
Change from baseline
次要结局
- Peritoneal equilibration test(28 days)
- Weekly total urea Kt/V(28 days)
- Weekly total creatinine clearance(28 days)
- Adverse Events(2 months)