Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

Exclusion Criteria

• •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.