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

Vantive Health LLC

Status and phase: Withdrawn; Phase 4

Conditions: Hypertriglyceridemia; Peritoneal Dialysis

Treatments: Drug: Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00397358

31656

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)