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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Collaborator: Hexal AG
• Treatments: Epoetin Alfa

Criteria

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.