Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)

Exclusion Criteria

• •Refractory to erythropoiesis stimulating agent (ESA) treatment
• •History of blood transfusion within 3 months
• •Donation or loss of blood for more than 400 milliliters (mL) within 8 weeks
• •History of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar ESA drugs
• •Acute or chronic organ seizure disorder (including asthma and chronic obstructive pulmonary disease) which may be clinically deteriorated by the drug administration
• •Active infection or history of infection that required intravenous injection of antibiotics in the last two months
• •Grand Mal epilepsy
• •Major surgery within 3 months other than access surgery
• •Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma
• •Ischemic stroke within 3 years
• •Chest x-ray findings determined that they cannot participate in the study for clinically abnormal findings by the baseline chest x-ray findings or previously taken chest x-ray findings
• •Uncontrolled hypertension
• •Congestive heart failure more severe than NYHA functional class III; unstable Coronary artery disease (CAD); myocardial infraction within 3 months
• •Uncontrolled arrhythmia
• •High risk of thrombosis and embolism
• •Systemic blood diseases (e.g. Pure red cell anemia, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia)
• •Absolute neutrophil count below 1,500 per microliter (uL) within screening periods
• •Platelet count less than 5e10 per liter (L) within screening periods
• •Hyperparathyrodism / hypothyrodism
• •Splenomegaly caused by anemia or severe splenomegaly (\>20cm)
• •Blood aspartate aminotransferase/alanine aminotransferase (ALT/AST) concentration exceeds three times Upper Normal Limit of Normal (UNL)
• •Blood total bilirubin concentration exceeds 1.5 times Upper Normal Limit of Normal (UNL)
• •Blood albumin concentration below 3g per deciliter (dl)
• •History of drug or alcohol abuse in the 6 months prior to the screening
• •History of psychotropic or narcotic analgesic drugs dependence within 6 months prior to the screening
• •Mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted
• •Lack of understanding of the study and cooperation (one with no intention to give efforts to perform each evaluation visit and extend previously planned elective surgery)
• •Female subjects with childbearing potential who are pregnant, breastfeeding or intends to become pregnant
• •Participation in any drug study within 30 days prior to dosing
• •Any other ineligible condition at the direction of the investigator that would be ineligible to participate the study