An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease

Phase 3 Completed 375 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.

Timeline

Start: 2006-09
Primary completion: 2008-02
Completion: 2008-02

Outcome

Met primary endpoint

paper RESULTS: Both the QW and Q2W regimens met the primary efficacy endpoint. PMID 19808215 ↗

Publications

Pergola PE, Gartenberg G, Fu M, Wolfson M, Rao S, Bowers P. A randomized controlled study of weekly and biweekly dosing of epoetin alfa in CKD Patients with anemia. Clin J Am Soc Nephrol. 2009 Nov;4(11):1731-40. doi: 10.2215/CJN.03470509. Epub 2009 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	50 iu/kg	Subcutaneous
Subject	epoetin alfa	Protein / enzyme biologic	10000 iu	Subcutaneous
Subject	epoetin alfa	Protein / enzyme biologic	20000 iu	Subcutaneous