A Study of Glucothera Plus for Peritoneal Dialysis in Children (ASTRA)

You may not qualify if:

• Male and female patients ≥ 18 years old
• Subjects with reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adesions
• Uncontrolled hyperphosphatemia
• Participation in a clinical trial with an investigational drug within one month prior start of study. Prior participation in this trial
• Suspicion of drug abuse
• Severe pulmonary, cardiac or hepatic disease/insufficiency
• Clinically significant abnormal liver function test (Gamma-GT > 4 times the upper normal limit and/or transaminases (AST and/or ALT) > 3 upper normal limits)
• Any kind of malignancy
• Lack of appropriate caregiver support
• Impeding/major abdominal surgery
• Enrolment in another clinical trial involving medical or device based interventions during a) the 30 days before the screening or b) 5-times the halflife of the used investigational product (the longest period should be considered).
• Ipersensibility to Glucose, L-Carnitine and other Glucothera Plus components
• Evidence of any condition that, according to the investigators’ judgment, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially affecting the study quality data.
• Female patients who are pregnant or breast-feeding or women of childbearing potential* not receiving adequate contraceptive methods