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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01693029
First received: September 21, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in hemoglobin levels over time [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    The incidence of antibody formation against epoetin will be tabulated with absolute and relative frequencies


Estimated Enrollment: 360
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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)
  • Novicrit® (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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693029

  Show 48 Study Locations
Sponsors and Collaborators
Sandoz
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01693029     History of Changes
Other Study ID Numbers: HX575-307
Study First Received: September 21, 2012
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sandoz:
erythropoietin alfa
CKD 5d

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014