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

This study has been completed.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00725517
First received: July 28, 2008
Last updated: July 31, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Peritoneal Dialysis
Drug: Icodextrin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • long dwell net peritoneal ultrafiltration [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: December 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Icodextrin group
Drug: Icodextrin
Icodextrin was used instead of Dianeal for long dwell time every day for 5 weeks.
Other Name: Extraneal dialysate
No Intervention: 2
Glucose group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725517

Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Jiaqi Qian, MD Renji Hospital, Shanghai Jiaotong University school of medicine
  More Information

No publications provided

Responsible Party: Jiaqi Qian, renji hospital, shanghai jiaotong university school of medicine
ClinicalTrials.gov Identifier: NCT00725517     History of Changes
Other Study ID Numbers: CN-R-001
Study First Received: July 28, 2008
Last Updated: July 31, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Icodextrin
ultrafiltration
creatinine clearance
urea nitrogen clearance

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Dialysis Solutions
Icodextrin
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014