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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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End Stage Renal Disease, Continuous Ambulatory Peritoneal Dialysis

Intervention / Treatment
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* Procedure: Blood samples
* Procedure: Measure of peritoneal ultrafiltrates


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dianeal only<br>Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange | Procedure: Blood samples<br>* Samples taken monthly<br>Procedure: Measure of peritoneal ultrafiltrates<br>* Measured by the investigators intermittently and by the patients themselves on a monthly basis<br>|
| Active Comparator: Dianeal; Extraneal long-dwell exchange<br>Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange | Procedure: Blood samples<br>* Samples taken monthly<br>Procedure: Measure of peritoneal ultrafiltrates<br>* Measured by the investigators intermittently and by the patients themselves on a monthly basis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |