Status:
COMPLETED
Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Chronic Kidney Disease
Peritoneal Dialysis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 Perit...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00725517
Start Date
December 1 2005
End Date
February 1 2007
Last Update
August 1 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.