Clinical Research Directory

Inclusion Criteria: * The patients signed the informe consent form and adhere to study visit schedule. * Male or female patients aged from 18 to 65 years. * Patients on hemodialysis or peritoneal dialysis for at least 3 months and have Hb baseline \<10 g/dL during the screening period. * Have transferrin saturation ≥ 20%, serum ferritin ≥ 200 ng/mL, vitamin B12 and folate within the normal range. * Have expected survival of at least 6 months from time of enrollment (by investigator's assessment). * Women childbearing age must agree to use medically acceptable methods of contraception during the study and for 6 months after the last study treatment. * The patient does not have any serious medical conditions that may affect to study treatment compliance. Exclusion Criteria: * Uncontrolled hypertension over 2 weeks prior to and within the screening period (BP ≥ 160/90 mmHg). * Patients treated with Darbepoetin alfa or r-HuEPO within 4 weeks prior to enrollment. * Patients with Uncontrolled diabetes mellitus with HbA1C ≥ 10%. * Congestive Heart Failure of grade 3 or 4 as New York Heart Association classification. * History of unstable angina or myocardial infarction within 6 months. * History of Grand mal seizures in last 2 years. * Present with severe hyperparathyroidism (iPTH \>1500 pg/mL for Dialysis). * History of major surgery within 12 weeks prior to screening. * Systemic hematologic disorders including sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma and hemolytic anemia. * Systemic infections, active inflammatory diseases and malignancies. * Active liver disease or hepatic with liver enzymes AST and ALT raised \> 2-times of laboratory normal values, child B or child C cirrhosis. * Are being treated with androgen therapy within the 8 weeks prior to the screening period. * Pregnant or suspected pregnant women, breast-feeding women. * Patients scheduled for any transplant procedure within 6 months of screening or with a previous history of kidney transplantation. * Patients who are hypersensitive to any of substances of investigational product. * Patients using drugs that can affect the concentration of Hb in the blood (except blood-forming drugs such as iron, folic acid). * Patients with seropositivity to HIV, HBV or anti-HCV. * Patients having acute tuberculosis or any acute bacterial infection within 1 month prior to the screening. * Patient has occult blood in stool or any other known source of internal bleeding and confirmed gastrointestinal bleeding by endoscopy. * Patients with blood transfusion due to acute bleeding within 12 weeks prior to screening period. * Patients with a history of immunosuppressive therapy within 1 month. * The patient is suffering from advanced cancer. * Patients having participated in any other clinical trial within 1 month prior to the screening period. * The patient had any medical condition that the investigator assessed as affecting the study.