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 |
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
46
sites
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Los Angeles, California 90025
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Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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