NCT00858182撤回2 期
Evaluation of a New Peritoneal Dialysis Solutions Containing Glucose, Xylitol and L-carnitine Compared to Standard PD Solutions in End-stage Renal Disease (ESRD) Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- To assess ultrafiltration efficacy of PD solutions containing L-Carnitine and Xylitol
研究概览
简要总结
A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as osmotic agents to partially replace glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age ≥18 years;
- •Diagnosis of ESRD treated for at least three month with CAPD, as stated by the medical staff of the center;
- •CAPD treatment with 2.27% of glucose solution for the nocturnal exchange;
- •Stable clinical condition within four weeks before screening period, certified by medical/surgical history, physical examination and laboratory exploration;
- •Hemoglobin level ≥9g/dL;
- •Residual diuresis ≤800mL;
- •Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
- •Stable peritoneal permeability, as confirmed by a PET between 0.50 and 0.81 during previous three months and at day 0 of the screening period;
- •Total urea Kt/V >1.5 per week at a control during previous three months and at day 0 of the screening period and/or minimal total creatinine clearance of 45 liter/week at a control during previous three months and at day 0 of the screening period; 1- To understand and sign an informed consent form.
- •For patients who will be included in Group B, the following criteria must be fulfilled too:
- •Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
- •Be treated with 2 or 3 diurnal exchange bag solutions (solution bags with 1.36% or 2.27% glucose) and one nocturnal exchange bag solution (Extraneal)
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 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 assessment of study parameters, especially if the life expectation is less then one year;
- •Participation in another clinical study within the past month;
- •Known or supposed allergic reactions to L-carnitine or xylitol.
研究组 & 干预措施
Group A
Experimental
干预措施: PD solution for nocturnal exchanges (Drug)
Group B
Experimental
干预措施: PD solution for diurnal exchanges (Drug)
结局指标
主要结局
To assess ultrafiltration efficacy of PD solutions containing L-Carnitine and Xylitol
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
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