Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange

A prospective, multicenter, randomized, double blind, parallel controlled study has been conducted for 5 weeks in 201 CAPD patients. These patients were randomized from 7 centers with 98 allocated to the Icodextrin group and 103 to the Dextrose group. Before study, conventional glucose-based solution was the only dialysate which can available in China. Extraneal® is one of peritoneal dialysate produced by Baxter which contains 7.5% Icodextrin. Patients involved the study were allocated to Dianeal group and Extraneal group in randomize. In Dianeal group, prescription was unchanged, while in Extraneal group, Extraneal dialysate was used instead of 2.5% Dianeal. Assessments at baseline, week 2, and week 4 included drain volume and levels of glucose, creatinine, and urea in the dialysate drained from the long dwell; physical examination; vital signs; drained body weight; laboratory analyses. Daily net peritoneal ultrafiltration, daily peritoneal creatine clearance and daily peritoneal urea nitrogen clearance were recorded prior to and 2 week, 4 week after commencing Extraneal.

Inclusion criteria

• Patients undergoing continuous ambulatory peritoneal dialysis (CAPD) for more than 90 days were included in the study.
• Over the age of 18
• Received a minimum of 6-8 liters of dialysis fluid per day and nighttime must lasted for 8-16 hours with 2.5% Dianeal® PD-2 or PD-4 dialysate, dwell volume was 2.0 liters before 30 days of screen visit
• No acute/chronic exit infection or tunnel infection accompany with peritonitis infection before 30 days of screen visit

Exclusion criteria

• Be sensitive to Icodextrin
• Suffer from other serious disease
• Attended other invention research which was approved by Ethics Committee
• Used other drugs in trial 30 days before screen visit.