Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis

Phase 3 Completed 420 enrolled Amgen

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis

Timeline

Start: 2005-09
Primary completion: 2007-01
Completion: 2007-01

Publications

Results Lei L, Olson K. Evaluating statistical methods to establish clinical similarity of two biologics. J Biopharm Stat. 2010 Jan;20(1):62-74. doi: 10.1080/10543400903115082.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	epoetin alfa	Protein / enzyme biologic	—	—

Indications

No indication recorded.