Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-06-30

Brief Summary

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This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.

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Detailed Description

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This prospective, open label, multi-center study evaluates the use of 7.5% icodextrin used in the long-dwell exchange in peritoneal dialysis patients with elevated triglyceride levels. Fasting triglyceride levels will be measured during the study.

Conditions

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Peritoneal Dialysis Hypertriglyceridemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* written informed consent
* CAPD/APD on dialysis for at least 3 months
* Elevated fasting triglyceride levels

Exclusion Criteria

* enrolled in another study requiring IRB approval
* allergy to starch-based polymers
* glycogen storage disease
* maltose or isomaltose intolerance
* active alcohol/substance abuse
* Pregnant or nursing
* received an investigational drug within 30 days of screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No