Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR (ECOS)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: End Stage Renal Disease; Continuous Ambulatory Peritoneal Dialysis
• Intervention / Treatment: Procedure: Blood samples; Procedure: Measure of peritoneal ultrafiltrates

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Bogota, Colombia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dianeal only; Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange	Procedure: Blood samples; Samples taken monthly; Procedure: Measure of peritoneal ultrafiltrates; Measured by the investigators intermittently and by the patients themselves on a monthly basis
Active Comparator: Dianeal; Extraneal long-dwell exchange; Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange	Procedure: Blood samples; Samples taken monthly; Procedure: Measure of peritoneal ultrafiltrates; Measured by the investigators intermittently and by the patients themselves on a monthly basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA index	Measure the changes in the levels of the HOMA index when Extraneal (7.5%) is being administered in the long-dwell exchange and compare these levels to the HOMA index resulting when using Dianeal 2.5% in the long-dwell exchange in non-diabetic CAPD patients. This outcome will be evaluated by measurements taken monthly over a period of 4 months.	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Mauricio R Sanabria, M.D., Baxter, RTS Colombia

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: ECOS