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

This study has been completed.
Information provided by (Responsible Party):
Sandoz Identifier:
First received: September 21, 2012
Last updated: June 1, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Chronic Kidney Disease (CKD)
Drug: HX575 epoetin alfa
Drug: US-licensed epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Mean absolute change in hemoglobin (Hb) levels between the screening/baseline period (week -4 to day 1) and the evaluation period (week 21 to week 28) [ Time Frame: week -4 to week 28 ]

Secondary Outcome Measures:
  • Change from baseline in hemoglobin levels over time [ Time Frame: 52 weeks ]
    Mean changes in Hb levels compared to screening/baseline will be presented by visit.

  • Change from baseline in the weekly epoetin dosage (International Unit [IU] and IU/kg) over time [ Time Frame: 52 weeks ]
    Absolute changes in the weekly epoetin dose (in total IU epoetin and in IU/kg body weight) compared to screening/baseline will be presented by week.

  • Incidence and severity of adverse events, and of drug related adverse events [ Time Frame: 52 weeks ]
    Incidences of Treatment Emergent Adverse Events (TEAEs), related TEAEs, treatment-emergent Serious Adverse Events (SAEs), and related SAEs will be summarized by the medical dictionary for regulatory activities (MedDRA) primary system organ class (SOC) and preferred term overall and, in addition, stratified by severity of the events.

  • Incidence of Antibody formation against Epoetin [ Time Frame: 52 weeks ]
    The incidence of antibody formation against epoetin will be tabulated with absolute and relative frequencies

Enrollment: 437
Study Start Date: September 2012
Study Completion Date: March 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HX575 epoetin alfa
HX575, recombinant human epoetin alfa
Drug: HX575 epoetin alfa
Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.
Other Names:
  • Binocrit® (Europe)
  • Epoetin alfa HEXAL® (Europe)
  • Abseamed® (Europe)
Active Comparator: US-licensed epoetin alfa
US-licensed recombinant human epoetin alfa
Drug: US-licensed epoetin alfa
Solution for subcutaneous injection.
Other Names:
  • Epogen®
  • Procrit®


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01693029

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Sponsors and Collaborators
  More Information

Responsible Party: Sandoz Identifier: NCT01693029     History of Changes
Other Study ID Numbers: HX575-307
Study First Received: September 21, 2012
Last Updated: June 1, 2016

Keywords provided by Sandoz:
erythropoietin alfa
CKD 5d

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics processed this record on April 27, 2017