Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange
Primary Purpose
Chronic Kidney Disease, Peritoneal Dialysis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Icodextrin
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Icodextrin, ultrafiltration, creatinine clearance, urea nitrogen clearance
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Icodextrin group
Glucose group
Outcomes
Primary Outcome Measures
long dwell net peritoneal ultrafiltration
Secondary Outcome Measures
long dwell peritoneal creatine clearance and long dwell peritoneal urea nitrogen clearance, physical examination; vital signs; drained body weight; laboratory analyses
Full Information
NCT ID
NCT00725517
First Posted
July 28, 2008
Last Updated
July 31, 2008
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00725517
Brief Title
Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange
Official Title
Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange in Continuous Ambulatory Peritoneal Dialysis Patients, Compare to 2.5% Dianeal Peritoneal Dialysis Solution.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Peritoneal Dialysis
Keywords
Icodextrin, ultrafiltration, creatinine clearance, urea nitrogen clearance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Icodextrin group
Arm Title
2
Arm Type
No Intervention
Arm Description
Glucose group
Intervention Type
Drug
Intervention Name(s)
Icodextrin
Other Intervention Name(s)
Extraneal dialysate
Intervention Description
Icodextrin was used instead of Dianeal for long dwell time every day for 5 weeks.
Primary Outcome Measure Information:
Title
long dwell net peritoneal ultrafiltration
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
long dwell peritoneal creatine clearance and long dwell peritoneal urea nitrogen clearance, physical examination; vital signs; drained body weight; laboratory analyses
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiaqi Qian, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange
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