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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00397358
First received: November 7, 2006
Last updated: June 29, 2007
Last verified: June 2007
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Icodextrin
U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

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

Enrollment: 0
Study Start Date: November 2006
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397358

Locations
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
Investigators
Study Director: Baxter Healthcare Corporation Call central contact for information
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00397358     History of Changes
Other Study ID Numbers: 31656
Study First Received: November 7, 2006
Last Updated: June 29, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Baxter Healthcare Corporation:
Peritoneal Dialysis
Hypertriglyceridemia
Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013