Research Into the Treatment of Anemia for Critically Ill Patients Admitted to Intensive Care Units (ICU)

NCT00091910 ↗

Phase 3 Completed 1460 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedSingle-groupDouble-blindDiagnostic

Summary

Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the production of red cells in the bone marrow. The purpose of this research study is to demonstrate that the administration EPO to critically ill subjects in the intensive care unit (ICU) reduces the number of patients requiring red blood cell (RBC) transfusion as compared with placebo (a liquid without active medicine).

Timeline

Start: 2003-09
Primary completion: —
Completion: 2006-06

Outcome

Missed primary endpoint

paper The use of epoetin alfa does not reduce the incidence of red-cell transfusion among critically ill patients PMID 17804841 ↗

Publications

Results Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	40000 iu	Subcutaneous