Status:
WITHDRAWN
Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Peritoneal Dialysis
Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 triglyc...
Eligibility Criteria
Inclusion
- written informed consent
- CAPD/APD on dialysis for at least 3 months
- Elevated fasting triglyceride levels
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00397358
Start Date
November 1 2006
End Date
June 1 2007
Last Update
March 3 2025
Active Locations (3)
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1
Kaiser Santa Clara - Homestead
Santa Clara, California, United States, 95051
2
Nephrology Specialists
Michigan City, Indiana, United States, 46360
3
Dialysis Center of Lincoln
Lincoln, Nebraska, United States, 68510