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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Baxter Healthcare Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01093547
First received: March 24, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Ultrafiltration of long-dwell exchange [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Hospitalization rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Time during hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093547

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

No publications provided

Responsible Party: Dr Mauricio Sanabria, Baxter Healthcare Corporation RTS Colombia
ClinicalTrials.gov Identifier: NCT01093547     History of Changes
Other Study ID Numbers: ECOS
Study First Received: March 24, 2010
Last Updated: March 24, 2010
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

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

ClinicalTrials.gov processed this record on August 01, 2014