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

Phase 4

Withdrawn

• Conditions: Peritoneal Dialysis; Hypertriglyceridemia

• Registration Number: NCT00397358
• Lead Sponsor: Vantive Health LLC

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-08
• Study First Posted: 2006-11-09
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in fasting triglyceride levels.

Trial Locations

Locations (3)

Kaiser Santa Clara - Homestead; 🇺🇸 Santa Clara, California, United States

Nephrology Specialists; 🇺🇸 Michigan City, Indiana, United States

Dialysis Center of Lincoln; 🇺🇸 Lincoln, Nebraska, United States