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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693029
First Posted: September 26, 2012
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sandoz
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (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 Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28) [ Time Frame: Week -4 to Day1 and Week 21-28 ]
    Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .

  • Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28) [ Time Frame: Week -4 to Day1 and Week 21-28 ]
    Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .


Secondary Outcome Measures:
  • Mean Weekly Dose During Evaluation Period (Week 21-28) [ Time Frame: Week 21-28 ]
    Mean weekly study drug dose during evaluation period (Week 21-28)

  • Incidence of Antibody Formation Against Epoetin [ Time Frame: 52 weeks ]
    Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.


Enrollment: 435
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®

Detailed 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).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693029


  Show 52 Study Locations
Sponsors and Collaborators
Sandoz
Investigators
Study Director: Sandoz Biopharmaceutical Clinical Development Sandoz Biopharmaceuticals
  More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01693029     History of Changes
Other Study ID Numbers: HX575-307
First Submitted: September 21, 2012
First Posted: September 26, 2012
Results First Submitted: April 4, 2017
Results First Posted: May 12, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sandoz:
erythropoietin alfa
CKD 5d

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics