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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397358
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : November 9, 2006
Last Update Posted : May 8, 2017
Information provided by:
Baxter Healthcare Corporation

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

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Hypertriglyceridemia Drug: Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients
Actual Study Start Date : November 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Icodextrin

Primary Outcome Measures :
  1. Change from baseline in fasting triglyceride levels.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00397358

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United States, California
Kaiser Santa Clara - Homestead
Santa Clara, California, United States, 95051
United States, Indiana
Nephrology Specialists
Michigan City, Indiana, United States, 46360
United States, Nebraska
Dialysis Center of Lincoln
Lincoln, Nebraska, United States, 68510
Sponsors and Collaborators
Baxter Healthcare Corporation
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Study Director: Baxter Healthcare Corporation Call central contact for information
Layout table for additonal information Identifier: NCT00397358    
Other Study ID Numbers: 31656
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Keywords provided by Baxter Healthcare Corporation:
Peritoneal Dialysis
Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Dialysis Solutions
Pharmaceutical Solutions