Back to resultsEffect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients
Primary Purpose
Peritoneal Dialysis, Hypertriglyceridemia
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Dialysis focused on measuring Peritoneal Dialysis, Hypertriglyceridemia, Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution
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
Sites / Locations
- Kaiser Santa Clara - Homestead
- Nephrology Specialists
- Dialysis Center of Lincoln
Outcomes
Primary Outcome Measures
Change from baseline in fasting triglyceride levels.
Secondary Outcome Measures
Full Information
NCT ID
NCT00397358
First Posted
November 7, 2006
Last Updated
May 5, 2017
Sponsor
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00397358
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
November 2006 (Actual)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Baxter Healthcare Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis, Hypertriglyceridemia
Keywords
Peritoneal Dialysis, Hypertriglyceridemia, Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution
Primary Outcome Measure Information:
Title
Change from baseline in fasting triglyceride levels.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter Healthcare Corporation
Organizational Affiliation
Call central contact for information
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Santa Clara - Homestead
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Nephrology Specialists
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Dialysis Center of Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10911641
Citation
Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
Results Reference
background
PubMed Identifier
11475343
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.
Results Reference
background
PubMed Identifier
15980620
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.
Results Reference
background
PubMed Identifier
12694323
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.
Results Reference
background
PubMed Identifier
11510303
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.
Results Reference
background
PubMed Identifier
16221697
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.
Results Reference
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Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients
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