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

May 5, 2017 updated by: Baxter Healthcare Corporation

Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Clara, California, United States, 95051
        • Kaiser Santa Clara - Homestead
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Nephrology Specialists
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Dialysis Center of Lincoln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in fasting triglyceride levels.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Investigators

  • Study Director: Baxter Healthcare Corporation, Call central contact for information

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 8, 2006

First Posted (Estimate)

November 9, 2006

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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