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.

This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who receive i.v. HX575 epoetin alfa treatment and to monitor the adverse event (AE) profile under post-approval conditions.

Inclusion Criteria:

• CKD subjects with or without dialysis treatment
• Age over 18 years
• Subjects requiring i.v. ESA treatment
• Subjects likely to remain on i.v. ESA treatment for 6 months
• Provision of informed consent -

Exclusion Criteria:

• Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level
• Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product
• History of PRCA or aplastic anemia
• History of anti-erythropoietin antibodies
• Uncontrolled hypertension
• Pregnant woman or nursing mother
• Women of childbearing potential do not agree to maintain effective birth control during the study treatment period.