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NCT00397358 Clinical Trial

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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00397358
Other study ID # 31656
Secondary ID
Status Withdrawn
Phase Phase 4
First received November 7, 2006
Last updated May 5, 2017
Start date November 2006
Est. completion date June 2007

Study information
Verified date May 2017
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution

Locations
Country Name City State
United States Dialysis Center of Lincoln Lincoln Nebraska
United States Nephrology Specialists Michigan City Indiana
United States Kaiser Santa Clara - Homestead Santa Clara California

Sponsors (1)
Lead Sponsor Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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

Kronenberg F, Lingenhel A, Neyer U, Lhotta K, König 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in fasting triglyceride levels.
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