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

Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00397358

Enrollment

Registered

2006-11-09

Start date

2006-11-30

Completion date

2007-06-30

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia, Peritoneal Dialysis

Keywords

Peritoneal Dialysis, Hypertriglyceridemia, Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution

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.

Interventions

DRUGExtraneal (7.5% icodextrin) Peritoneal Dialysis Solution

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in fasting triglyceride levels.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026