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

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00725517

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Peritoneal Dialysis	Drug: Icodextrin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Icodextrin group	Drug: Icodextrin Icodextrin was used instead of Dianeal for long dwell time every day for 5 weeks. Other Names: Extraneal dialysate
No Intervention: 2 Glucose group

Arm

Intervention/Treatment

Experimental: 1

Icodextrin group

Drug: Icodextrin

Icodextrin was used instead of Dianeal for long dwell time every day for 5 weeks.

Other Names:

Extraneal dialysate

No Intervention: 2

Glucose group

Outcome Measures

Primary Outcome Measures

long dwell net peritoneal ultrafiltration [5 weeks]

Secondary Outcome Measures

long dwell peritoneal creatine clearance and long dwell peritoneal urea nitrogen clearance, physical examination; vital signs; drained body weight; laboratory analyses [5 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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