Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR

Multi-centre, Open-label, Randomized Trial to Determine the Effect of Icodextrin (Extraneal) Versus Dextrose (Dianeal 2.5%) Used in Long-dwell Exchange, Measuring the HOMA Index in Non-diabetic Prevalent CAPD Patients

Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.

Inclusion Criteria:

• must be over 18-years old and under 75-years old
• Peritoneal Equilibration Test (PET) result of high, high average or low average transport
• non-diabetic patient
• be in Continuous Ambulatory Peritoneal Dialysis (CAPD)
• prevalent patients that have been in peritoneal dialysis at least 30 days
• wish to participate

Exclusion Criteria:

• Have a Charlson score of >7 and have a life expectancy of less than 12 months
• HIV positive
• present with peritonitis in the month prior to randomisation
• present with cardiovascular, metabolic or infection complications that have required hospitalisation in the month prior to the randomisation
• have active cancer
• pregnant women
• patients with known allergy to starch-based polymer
• patients who have a significant psychiatric disorder or mental disability that could interfere with the patient´s ability to provide Informed Consent and comply with the protocol procedures
• women incapable of maintaining an effective and accepted contraception method