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

Sandoz

Status and phase: Completed; Phase 3

Conditions: Anemia; Chronic Kidney Disease (CKD)

Treatments: Drug: US-licensed epoetin alfa; Drug: HX575 epoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01693029

HX575-307

Details and patient eligibility

About

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.

Full description

This is a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in the treatment of anemia associated with chronic kidney disease (CKD).

Enrollment: 435 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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435 participants in 2 patient groups

HX575 epoetin alfa

Experimental group

Description:

HX575, recombinant human epoetin alfa

Treatment:

Drug: HX575 epoetin alfa

US-licensed epoetin alfa

Active Comparator group

Description:

US-licensed recombinant human epoetin alfa

Treatment:

Drug: US-licensed epoetin alfa