Overview

This trial is active, not recruiting.

Conditions end stage renal disease, continuous ambulatory peritoneal dialysis
Treatments blood samples, measure of peritoneal ultrafiltrates
Phase phase 4
Sponsor Baxter Healthcare Corporation
Start date February 2010
End date July 2011
Trial size 120 participants
Trial identifier NCT01093547, ECOS

Summary

Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange
blood samples
Samples taken monthly
measure of peritoneal ultrafiltrates
Measured by the investigators intermittently and by the patients themselves on a monthly basis
(Active Comparator)
Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange
blood samples
Samples taken monthly
measure of peritoneal ultrafiltrates
Measured by the investigators intermittently and by the patients themselves on a monthly basis

Primary Outcomes

Measure
HOMA index
time frame: 4 months

Secondary Outcomes

Measure
HbA1c
time frame: 12 months
Ultrafiltration of long-dwell exchange
time frame: 12 months
Blood pressure
time frame: 12 months
Quality of life
time frame: 12 months
Hospitalization rate
time frame: 12 months
Time during hospitalization
time frame: 12 months
Incidence of Adverse Events
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - must be over 18-years old and under 75-years old - Peritoneal Equilibration Test (PET) result of high, high average or low average transport - non-diabetic patient - be in Continuous Ambulatory Peritoneal Dialysis (CAPD) - prevalent patients that have been in peritoneal dialysis at least 30 days - wish to participate Exclusion Criteria: - Have a Charlson score of >7 and have a life expectancy of less than 12 months - HIV positive - present with peritonitis in the month prior to randomisation - present with cardiovascular, metabolic or infection complications that have required hospitalisation in the month prior to the randomisation - have active cancer - pregnant women - patients with known allergy to starch-based polymer - patients who have a significant psychiatric disorder or mental disability that could interfere with the patient´s ability to provide Informed Consent and comply with the protocol procedures - women incapable of maintaining an effective and accepted contraception method

Additional Information

Official title Multi-centre, Open-label, Randomized Trial to Determine the Effect of Icodextrin (Extraneal) Versus Dextrose (Dianeal 2.5%) Used in Long-dwell Exchange, Measuring the HOMA Index in Non-diabetic Prevalent CAPD Patients
Principal investigator Mauricio R Sanabria, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Baxter Healthcare Corporation.