Clinical trial NCT00397358: Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Peritoneal Dialysis
Hypertriglyceridemia
Keywords: Peritoneal Dialysis
Hypertriglyceridemia
Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2006-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Change from baseline in fasting triglyceride levels.
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Kaiser Santa Clara - Homestead
state: California
city: Michigan City
country: United States
facility: Nephrology Specialists
state: Indiana
city: Lincoln
country: United States
facility: Dialysis Center of Lincoln
state: Nebraska
Study officials:
affiliation: Call central contact for information
name: Baxter Healthcare Corporation
role: STUDY_DIRECTOR
References:
citation: Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
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.
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. doi: 10.1159/000086553. Epub 2005 Jun 23.
citation: 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. doi: 10.1046/j.1523-1755.63.s84.23.x.
citation: 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.
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. doi: 10.1093/ndt/gfi197. Epub 2005 Oct 12.