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

End Stage Renal Disease Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01093547
• Other study ID #: ECOS
• Status: Withdrawn
• Phase: Phase 4
• First received: March 24, 2010
• Last updated: October 18, 2017
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Continuous Ambulatory Peritoneal Dialysis
• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• Blood samples
Samples taken monthly
• Measure of peritoneal ultrafiltrates
Measured by the investigators intermittently and by the patients themselves on a monthly basis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c		12 months
Secondary	Ultrafiltration of long-dwell exchange		12 months
Secondary	Blood pressure		12 months
Secondary	Quality of life		12 months
Secondary	Hospitalization rate		12 months
Secondary	Time during hospitalization		12 months
Secondary	Incidence of Adverse Events		12 months