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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:September 2012
End Date:September 2014
Contact:Sandoz Biopharmaceuticals
Phone:+49-8024-476-0

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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


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.


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
We found this trial at
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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77 Cadillac Drive
Sacramento, California 95825
916-929-8564
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Albuquerque, New Mexico 87109
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Alexandria, Virginia 22304
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Austin, Texas 78756
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Azusa, California 91702
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Bakersfield, California 93309
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Bakersfield, California 93308
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Bethlehem, Pennsylvania 18017
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Brooklyn, New York 11355
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Charlotte, North Carolina 28204
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Coral Springs, Florida 33071
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Germantown, Maryland 20874
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Hollywood, Florida 33020
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Houston, Texas 77074
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Houston, Texas 77030
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Knoxville, Tennessee 37923
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La Mesa, California 91942
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Laguna Hills, California 92653
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Las Vegas, Nevada 89106
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Lynwood, California 90262
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Morgantown, West Virginia 26506
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Northridge, California 91324
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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Ontario, California 91762
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Orangeberg, South Carolina 29118
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Portsmouth, New Hampshire 03801
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Riverside, California
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Rocky Mount, North Carolina 27804
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San Diego, California 92154
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Shreveport, Louisiana 71101
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