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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093547
First Posted: March 26, 2010
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  Purpose
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.

Condition Intervention Phase
End Stage Renal Disease Continuous Ambulatory Peritoneal Dialysis Procedure: Blood samples Procedure: Measure of peritoneal ultrafiltrates Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • HOMA index [ Time Frame: 4 months ]
    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 [ 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 ]

Enrollment: 0
Anticipated Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093547


Locations
Colombia
Bogota, Colombia
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Mauricio R Sanabria, M.D. Baxter, RTS Colombia
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01093547     History of Changes
Other Study ID Numbers: ECOS
First Submitted: March 24, 2010
First Posted: March 26, 2010
Last Update Posted: October 20, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions