Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients - Full Text View

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00397358

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 IV

MedlinePlus related topics: Kidney Failure Triglycerides

Drug Information available for: Icodextrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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:

Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41. Review.

Bredie SJ, Bosch FH, Demacker PN, Stalenhoef AF, van Leusen R. Effects of peritoneal dialysis with an overnight icodextrin dwell on parameters of glucose and lipid metabolism. Perit Dial Int. 2001 May-Jun;21(3):275-81.

Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A. Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. Epub 2005 Jun 23.

Kronenberg F, Lingenhel A, Neyer U, Lhotta K, Konig P, Auinger M, Wiesholzer M, Andersson H, Dieplinger H. Prevalence of dyslipidemic risk factors in hemodialysis and CAPD patients. Kidney Int Suppl. 2003 May;(84):S113-6.

Amici G, Orrasch M, Da Rin G, Bocci C. Hyperinsulinism reduction associated with icodextrin treatment in continuous ambulatory peritoneal dialysis patients. Adv Perit Dial. 2001;17:80-3.

Furuya R, Odamaki M, Kumagai H, Hishida A. Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. Epub 2005 Oct 12.

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

Keywords provided by Baxter Healthcare Corporation:

Peritoneal Dialysis
Hypertriglyceridemia
Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Hypertriglyceridemia

Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009