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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00725517
• Date of registration: 28/07/2008
• Primary sponsor: Shanghai Jiao Tong University School of Medicine
• Public title: Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange
• Scientific 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.
• Date of first enrolment: December 2005
• Target sample size: 2
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00725517
• 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

Contacts

• Name: Jiaqi Qian, MD
• Affiliation: Renji Hospital, Shanghai Jiaotong University school of medicine

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Peritoneal Dialysis

Intervention(s)

Drug: Icodextrin

Primary Outcome(s)

long dwell net peritoneal ultrafiltration [Time Frame: 5 weeks]

Secondary Outcome(s)

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]

Secondary ID(s)

CN-R-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors