The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients

Exclusion Criteria

• •History of Pure Red Cell Aplasia (PRCA) or anti-epoetin antibodies.
• •Contraindications for ESA therapy.
• •Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level.
• •History of uncontrolled hypertension (defined as systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg during screening).
• •Any blood transfusion within the last 2 weeks prior to screening period.
• •Major surgery within 3 months prior to screening period.
• •Myelodysplastic syndrome.
• •History bleeding disorders (e.g. Hemophilia, Von Willebrand, and any conditions that result when the blood cannot clot properly).
• •Known bone marrow fibrosis (osteitis fibrosa cystica).
• •Known epilepsy.
• •Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites).
• •Systemic lupus erythematosus.
• •Previously diagnosed with HIV or acute hepatitis infection.
• •History of malignancy of any organ system within the last 5 year.
• •Pregnancy or lactation period in female patients.
• •Heavy smoker (who smoke over 20 cigarettes daily in average).