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

NCT00725517 | Completed Phase 4 DMC

• 1 other identifier: CN-R-001
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease; Peritoneal Dialysis

Keywords

Icodextrin; ultrafiltration; creatinine clearance; urea nitrogen clearance

Outcome Measures

Primary Outcomes (1)

• long dwell net peritoneal ultrafiltration

  5 weeks

Secondary Outcomes (1)

• long dwell peritoneal creatine clearance and long dwell peritoneal urea nitrogen clearance, physical examination; vital signs; drained body weight; laboratory analyses

  5 weeks

Study Arms (2)

1

EXPERIMENTAL

Icodextrin group

Drug: Icodextrin

2

NO INTERVENTION

Glucose group

Interventions

Icodextrin DRUG

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

Also known as: Extraneal dialysate

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Icodextrin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• Jiaqi Qian, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: December 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: August 1, 2008

Record last verified: 2008-07