HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Epoetin Alfa

Criteria

Main Inclusion Criteria:

• Adult male and female patients w or w/o dialysis treatment

• Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.

• Adequate iron substitution

Main Exclusion Criteria:

• History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies

• Contraindications for ESA therapy

• Serum albumin < 3.0 g/dL

• Immunocompromized patients (immunosuppressive treatment, chemotherapy)

• Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection

• Systemic lupus erythematosus

• Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months

• History of malignancy of any organ system within the last 5 years

• History of use of any non-EU approved ESA