CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Lipidose +1 moredrug
Likely dose
Lipidose 1.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00506454
NCT00506454Phase 2Completed
CompareCT.gov

A Phase II, Double-Blind, Placebo-Controlled, Randomized Study of the Effects of a Lipid Emulsion (Lipidose) on Endotoxin Levels in Patients on Chronic Hemodialysis

Sepsicure·interventional·Posted Jul 25, 2007·Updated Sep 20, 2011

In Brief

A Phase 2 clinical trial evaluating Lipidose and Placebo for Fatigue and End Stage Renal Disease (ESRD). Completed, enrolled 22 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether a phospholipid emulsion is effective in the treatment of chronic endotoxemia in hemodialysis patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue, End Stage Renal Disease (ESRD)
CountriesUnited States
CollaboratorsThe Rogosin Institute

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2007
Enrollment StartAug 1, 2007
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.9 years ago

Interventions

Lipidosedrug

Over the course of 2 weeks, immediately following subject's three (Monday/Wednesday/Friday (M/W/F)) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of Lipidose over a 2-hour period.

Placebodrug

Over the course of 2 weeks, immediately following subject's three (M/W/F) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of placebo over a 2-hour period.