Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.

Summary

Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

Timeline

Start

2008-07

Primary completion

2010-03

Completion

2010-09

Publications

• Horl WH, Locatelli F, Haag-Weber M, Ode M, Roth K; Epo-PASS study group. Prospective multicenter study of HX575 (biosimilar epoetin-alpha) in patients with chronic kidney disease applying a target hemoglobin of 10--12 g/dl. Clin Nephrol. 2012 Jul;78(1):24-32. doi: 10.5414/cn107440.

Drugs

Indications