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

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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Withdrawn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

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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