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

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.

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis; Chronic Kidney Disease
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
long dwell net peritoneal ultrafiltration	5 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
long dwell peritoneal creatine clearance and long dwell peritoneal urea nitrogen clearance, physical examination; vital signs; drained body weight; laboratory analyses	5 weeks

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jiaqi Qian, MD, Renji Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: July 28, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 30, 2008

Study Record Updates

• Last Update Posted (Estimate): August 1, 2008
• Last Update Submitted That Met QC Criteria: July 31, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Icodextrin; ultrafiltration; creatinine clearance; urea nitrogen clearance
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Pharmaceutical Solutions; Dialysis Solutions; Icodextrin
• Other Study ID Numbers: CN-R-001