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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of a 7.5% Icodextrin peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) in Chinese uremic patients.Patients were divided into Dianeal group or Extraneal group for long dwell time. Net ultrafiltration, small solute clearance and relationship between different transport group were used to evaluate efficacy of Icodextrin. Physical examination, vital signs and laboratory tests were used to evaluate safety of Icodextrin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Dialysis Solutions; Icodextrin

Criteria

Inclusion Criteria:

1. Patients undergoing continuous ambulatory peritoneal dialysis (CAPD) for more than 90 days were included in the study.

2. Over the age of 18

3. 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

4. No acute/chronic exit infection or tunnel infection accompany with peritonitis infection before 30 days of screen visit

Exclusion Criteria:

1. Be sensitive to Icodextrin

2. Suffer from other serious disease

3. Attended other invention research which was approved by Ethics Committee

4. Used other drugs in trial 30 days before screen visit.