NCT00506454 (LIPIDOSE) is a Phase 2 clinical trial of Lipidose in Fatigue, sponsored by Sepsicure.

Who is sponsoring NCT00506454?

NCT00506454 is sponsored by Sepsicure.

What drugs are being tested in NCT00506454?

Interventions in NCT00506454: Lipidose, Placebo.

What condition does NCT00506454 study?

NCT00506454 studies Fatigue, End Stage Renal Disease (ESRD).

Is NCT00506454 still recruiting?

NCT00506454 is currently completed. Last updated 16 September 2011.

Are results published for NCT00506454?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2011-09-16 · How we verify

NCT00506454: LIPIDOSE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 16 September 2011

What this trial tests

Phase 2 trial testing Lipidose in Fatigue in 22 participants. Completed in 1 February 2008.

Timeline

1 August 2007

Primary endpoint
1 February 2008

1 February 2008

Quick facts

Lead sponsor	Sepsicure
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	22
Start date	1 August 2007
Primary completion	1 February 2008
Estimated completion	1 February 2008
Sites	1 location across United States

Drugs / interventions tested

Lipidose — full drug profile →
Placebo

Conditions studied

Fatigue — all drugs for Fatigue →
End Stage Renal Disease (ESRD) — all drugs for End Stage Renal Disease (ESRD) →

Sponsor

Sepsicure — full company profile →

Who can join

18 and older, any sex, with Fatigue or End Stage Renal Disease (ESRD). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Reduction in Endotoxin Levels.
Time frame: Baseline and at 4 weeks
The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Fatigue

Currently open trials in the same condition.

NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
NCT07421960 — Investigation of the Relationship Between Periodontitis and Sleep Quality · recruiting
NCT07071324 — CF Wellness Program · NA · recruiting
NCT07386691 — Comparing Effect of Intradialytic Aerobic Exercise Versus Incentive Spirometer on Fatigue and Sleep Quality Among Hemodi · NA · active not recruiting
NCT06819254 — Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00506454 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sepsicure
Last refreshed: 16 September 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00506454.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing