A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia .

Exclusion Criteria

• •1. Patients with a history of severe allergies (including drug allergies), especially allergic to erythropoietin, or to any component of the test drug (e.g. polyethylene glycol);
• •2. Have a history of kidney transplantation or plan to undergo kidney transplantation during the trial；
• •3. Have any other disease that causes chronic anemia (e.g., sickle cell anemia, myelodysplastic syndrome, hematologic malignancy, myeloma, hemolytic anemia, pure red cell aplastic anemia) or PRCA following therapy of erythropoietin protein;
• •4. Suffered from acute or chronic blood loss (such as gastrointestinal bleeding) or undergwent surgical procedures due to massive bleeding within 3 months before screening, or plan to have a surgery during the clinical trial (except for arteriovenous fistula or peritoneal dialysis tube adjustment);
• •5. Have a history of malignant tumors within the past 5 years (excluding non-melanoma skin cancer or excised carcinoma in situ);
• •6. Suffer from autoimmune diseases (such as rheumatoid arthritis or systemic lupus erythematosus) or diseases of endocrine system (such as poorly controlled diabetes mellitus complicated with peripheral vascular diseases, severe secondary hyperparathyroidism \[parathyroid hormone \> 800ng/L\]);
• •7. Received systemic antibiotic treatment or C-reactive protein ≥30mg/L within 4 weeks due to severe infection before screening;
• •8. The following conditions occur during screening period:
• •Hepatic dysfunction (AST or ALT\>3 times ULN); Coagulation dysfunction (activated partial thrombin time \> 1.5 times ULN); Folic acid or vitamin B12 deficiency (serum folic acid level \<LLN, vitamin B12 \<LLN); Positive for HBsAg, HBcAb, HIV-ABb, HCV-AbB or TP-Ab;
• •9. Suffer from severe thromboembolic disease, poorly controlled severe hypertension (SBP before dialysis \> 170mmHg or DBP ≥100mmHg) or hypotension (SBP before dialysis \<90mmHg);
• •10. Suffer from severe cardiovascular and cerebrovascular disease, severe or unstable coronary artery disease, heart failure (NYHA CLASS III or IV), or those who received coronary artery bypass grafting or percutaneous coronary intervention within 6 months, or those who had a history of myocardial infarction or stroke within 3 months;
• •11. Received androgen therapy or blood transfusion within 8 weeks before screening period;
• •12. Received long-acting ESAs within 3 months or HIF-PHI (e.g., rosalat) within 2 weeks before initial administration;
• •13. Participated in other clinical trials as a subject within 4 weeks before screening period or the duration from the last administration to enrollment was shorter than the 5 half-lives of the drug;
• •14. Have a history of epileptic seizures or mental illness;
• •15. Alcoholism, drug abuse or drug addiction
• •16. Pregnant or breastfeeding;
• •17. Investigator considers not suitable to enter this trial.