Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 10
- 主要终点
- Net-ultrafiltration
研究概览
简要总结
Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD solution for long dwell exchange.
详细描述
The use of a solution icodextrin, xylitol and carnitine (IXC) as the osmotic agent in dialysate for the long dwell exchange provides sustained ultrafiltration (UF) through colloid osmosis, allowing a consistent reduction in extracellular fluid volume without the expected fall in urine output. The other major advantage of IXC is the reduced exposure and absorption of glucose as the main osmotic agent in PD therapy. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal IXC-based PD solution. Compared to glucose, indeed, carnitine and xylitol are extremely stable naturally occurring compounds, even at temperatures higher than those used to steam-sterilize infusional product. As a consequence, xylitol and carnitine may represent better alternatives than glucose as an osmotic ingredient both from the manufacturing and biocompatibility standpoints. Moreover, xylitol and carnitine have an excellent safety profile and possess distinct systemic actions, which are more favorable than glucose.
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
- •Diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) for at least 3 months
- •A stable clinical condition during the two weeks immediately prior to randomization
- •Blood hemoglobin concentration above 8,5 g/100ml
- •Has not experienced peritonitis episodes in the last 3 months
- •Treated with Extraneal for at least 1 month
- •Peritoneal Equilibration Test (PET) performed in the last three months
- •Has understood and signed the Informed Consent Form.
排除标准
- •History of drug or alcohol abuse in the six months prior to entering the protocol
- •Acute infectious condition
- •History of severe congestive heart failure and clinically significant arrhythmia
- •Malignancy within the past 5 years, including lymphoproliferative disorders
- •A medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug
- •A clinically relevant under-hydration as judged by the treating physician
- •History of L-Carnitine therapy or use in the month before entering the study
- •Received any investigational drug in the 3 months before entering the study
- •Pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive measures
研究组 & 干预措施
IXC Peritoneal dialysis solution
IXC (Icodextrin, Xylitol and L-Carnitine) Peritoneal dialysis solution
干预措施: Icodextrin, xylitol and carnitine solution for peritoneal dialysis (Drug)
Icodextrin
Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution
干预措施: EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution (Drug)
结局指标
主要结局
Net-ultrafiltration
时间窗: Changes from baseline value at the end of each product administration period (3 days)
Net Ultrafiltration at 10 hours (duration of long dwell), in mL, is defined as the difference between the weight of drained volume and weight of the effluent (fill volume).
次要结局
- Sodium removal(Calculated every day for 3 days during each product administration period.)
- Adverse Events(Through study completion, an average of 21 days.)
- Xylitol plasmatic level(Every day for 3 days during each product administration and during the wash-out period.)
- Carnitine plasmatic level(Every day for 3 days during each product administration and during the wash-out period)
- Xylitol absorption(Every day for 3 days during each product administration)