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

Phase 4

Withdrawn

• Conditions: End Stage Renal Disease; Continuous Ambulatory Peritoneal Dialysis
• Interventions: Procedure: Blood samples; Procedure: Measure of peritoneal ultrafiltrates

• Registration Number: NCT01093547
• Lead Sponsor: Vantive Health LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-26
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dianeal only	Measure of peritoneal ultrafiltrates	Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange
Dianeal only	Blood samples	Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange
Dianeal; Extraneal long-dwell exchange	Blood samples	Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange
Dianeal; Extraneal long-dwell exchange	Measure of peritoneal ultrafiltrates	Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange

Primary Outcome Measures

Name	Time	Method
HOMA index	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

Name	Time	Method
HbA1c	12 months
Ultrafiltration of long-dwell exchange	12 months
Blood pressure	12 months
Quality of life	12 months
Hospitalization rate	12 months
Time during hospitalization	12 months
Incidence of Adverse Events	12 months