A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis

A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis

Objective: The purpose of this study is to demonstrate:

-the non-inferiority of an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis patients.

Inclusion Criteria:

• Patients who have given written informed consent after the nature of the study has been explained.
• Patients who are at least 18 years of age.
• Patients who have been treated with CAPD using specific solutions for at least 60 days before the baseline visit.

Exclusion Criteria:

• Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit. - Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit.
• Patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection.
• Patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit.
• Patients who have severe malnutrition (serum albumin < 25 g/l by bromocresol green method).
• Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
• Patients who have received an investigational product within 30 days preceding the screening visit.
• Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).
• Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.