Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis

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.