NCT01093547

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease
• Continuous Ambulatory Peritoneal Dialysis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-07-01
• Completion: 2011-12-01
• First posted: 2010-03-26
• Last updated: 2025-03-13

Locations

1 site across 1 country: Colombia