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

Vantive Health LLC

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Peritoneal Dialysis Hypertriglyceridemia

Interventions

Extraneal (7.5% icodextrin) Peritoneal Dialysis SolutionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Change from baseline in fasting triglyceride levels.

Data from ClinicalTrials.gov

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