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

Inclusion Criteria:

1. Male and female patients at the age of 18~75 (including critical value).
2. Patients clinically diagnosed with renal anemia who have received dialysis for atleast 12 weeks (hemodialysis≥3 times/week, total urea clearance index (Kt/V) ≥1.2 orurea reduction rate (URR) ≥65%; peritoneal dialysis≥4 times/day, weekly Kt/V≥1.7);
3. Hb in screening period should be within the range of 100~130g/L (including both ends),and the deviation should not exceed 10g/L;
4. Iron status (TSAT ≥20% or SF ferritin ≥100μg/L) during screening.
5. Have been stably treated with short-acting EPO 1-3 times per week for at least 12weeks before baseline;
6. Consent to use reliable contraceptive methods and no family planning from thescreening period to 3 months after the last administration；
7. Voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Patients with a history of severe allergies (including drug allergies), especiallyallergic to erythropoietin, or to any component of the test drug (e.g. polyethyleneglycol);
2. Have a history of kidney transplantation or plan to undergo kidney transplantationduring the trial；
3. Have any other disease that causes chronic anemia (e.g., sickle cell anemia,myelodysplastic syndrome, hematologic malignancy, myeloma, hemolytic anemia, pure redcell aplastic anemia) or PRCA following therapy of erythropoietin protein;
4. Suffered from acute or chronic blood loss (such as gastrointestinal bleeding) orundergwent surgical procedures due to massive bleeding within 3 months beforescreening, or plan to have a surgery during the clinical trial (except forarteriovenous fistula or peritoneal dialysis tube adjustment);
5. Have a history of malignant tumors within the past 5 years (excluding non-melanomaskin cancer or excised carcinoma in situ);
6. Suffer from autoimmune diseases (such as rheumatoid arthritis or systemic lupuserythematosus) or diseases of endocrine system (such as poorly controlled diabetesmellitus complicated with peripheral vascular diseases, severe secondaryhyperparathyroidism [parathyroid hormone > 800ng/L]);
7. Received systemic antibiotic treatment or C-reactive protein ≥30mg/L within 4 weeksdue to severe infection before screening;
8. The following conditions occur during screening period: Hepatic dysfunction (AST or ALT>3 times ULN); Coagulation dysfunction (activatedpartial thrombin time > 1.5 times ULN); Folic acid or vitamin B12 deficiency (serumfolic acid level <LLN, vitamin B12 <LLN); Positive for HBsAg, HBcAb, HIV-ABb, HCV-AbBor TP-Ab;
9. Suffer from severe thromboembolic disease, poorly controlled severe hypertension (SBPbefore dialysis > 170mmHg or DBP ≥100mmHg) or hypotension (SBP before dialysis <90mmHg);
10. Suffer from severe cardiovascular and cerebrovascular disease, severe or unstablecoronary artery disease, heart failure (NYHA CLASS III or IV), or those who receivedcoronary 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 weeksbefore initial administration;
13. Participated in other clinical trials as a subject within 4 weeks before screeningperiod 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.