Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

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

Details

• Lead Sponsor: Sandoz
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week

• Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period

• Adequate iron substitution

Exclusion Criteria:

• Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy

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

• Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection

• Hepatitis C infection on an active treatment

• Symptomatic congestive heart failure (New York Heart Association [NYHA] class III and IV)

• Unstable angina pectoris, or cardiac infarction during the last 6 months prior to randomization

• Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization

• History of malignancy of any organ system

• Systemic lupus erythematous

• Immunocompromized patients

Other In-/Exclusion criteria may apply