The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
417
Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
Anti-Erythropoietin (EPO) Antibodies
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
Time frame: 52 weeks
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)
Time frame: 52 weeks
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Sandoz Investigative Site
Düsseldorf, Germany
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Homberg (Efze), Germany
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Nettetal, Germany
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Bari, Italy
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Częstochowa, Poland
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Gdansk, Poland
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Gdynia, Poland
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Olkusz, Poland
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Poznan, Poland
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Płock, Poland
...and 40 more locations