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

Baxter

Status and phase: Withdrawn; Phase 4

Conditions: Continuous Ambulatory Peritoneal Dialysis; End Stage Renal Disease

Treatments: Procedure: Blood samples; Procedure: Measure of peritoneal ultrafiltrates

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093547

ECOS

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Dianeal only

Active Comparator group

Description:

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

Treatment:

Procedure: Measure of peritoneal ultrafiltrates

Procedure: Blood samples

Dianeal; Extraneal long-dwell exchange

Active Comparator group

Description:

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

Treatment:

Procedure: Measure of peritoneal ultrafiltrates

Procedure: Blood samples