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

Primary Purpose

End Stage Renal Disease, Continuous Ambulatory Peritoneal Dialysis

Status
Withdrawn
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Blood samples
Measure of peritoneal ultrafiltrates
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dianeal only

Dianeal; Extraneal long-dwell exchange

Arm Description

Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange

Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

HbA1c
Ultrafiltration of long-dwell exchange
Blood pressure
Quality of life
Hospitalization rate
Time during hospitalization
Incidence of Adverse Events

Full Information

First Posted
March 24, 2010
Last Updated
October 18, 2017
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01093547
Brief Title
Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR
Acronym
ECOS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Study Start Date
February 2010 (Anticipated)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Continuous Ambulatory Peritoneal Dialysis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dianeal only
Arm Type
Active Comparator
Arm Description
Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange
Arm Title
Dianeal; Extraneal long-dwell exchange
Arm Type
Active Comparator
Arm Description
Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange
Intervention Type
Procedure
Intervention Name(s)
Blood samples
Intervention Description
Samples taken monthly
Intervention Type
Procedure
Intervention Name(s)
Measure of peritoneal ultrafiltrates
Intervention Description
Measured by the investigators intermittently and by the patients themselves on a monthly basis
Primary Outcome Measure Information:
Title
HOMA index
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
12 months
Title
Ultrafiltration of long-dwell exchange
Time Frame
12 months
Title
Blood pressure
Time Frame
12 months
Title
Quality of life
Time Frame
12 months
Title
Hospitalization rate
Time Frame
12 months
Title
Time during hospitalization
Time Frame
12 months
Title
Incidence of Adverse Events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio R Sanabria, M.D.
Organizational Affiliation
Baxter, RTS Colombia
Official's Role
Principal Investigator
Facility Information:
City
Bogota
Country
Colombia

12. IPD Sharing Statement

Learn more about this trial

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

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