Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria to be eligible forparticipation in this study:

1. Males or females ≥18 and ≤70 years of age, weight ≥ 45 kilograms (kg).
2. Females of child-bearing potential who are sexually active had to be willing topractice a highly effective method of birth control for at least 4 weeks prior torandomization, and had to be willing to continue contraception until at least 4weeks after the last dose of study treatment.
3. Participants with chronic renal failure on dialysis（hemodialysis/ peritonealdialysis） for ≥ 3 months prior to randomization，and that the frequency ofdialysis was stable and no change in dialysis pattern was observed during thetrial.
4. On ESAs treatment for ≥8 weeks prior to screening stage with stable doses and theaverage doses ≤ 10000 IU/week. And two consecutive hemoglobin values ≥10.0 g/dLand ≤12.0 g/dL within 4 weeks prior to randomization.
5. At least one transferrin saturation (TSAT) ≥ 20% and one serum ferritin (SF)level ≥ 100 ng/ml within 4 weeks prior to randomization. At least one serumfolate level and vitamin B12 level ≥ lower limit of normal during the 4 weeksprior to randomization.
6. Patient was informed of the investigational nature of the study and had givenwritten, informed consent in accordance with institutional, local, and nationalguidelines.

Exclusion Criteria:

• Subjects who meet any of the following exclusion criteria are not to be enrolled inthis study:

1. Females who were pregnant or breast-feeding.
2. Red blood cell (RBC) or whole blood transfusion within 12 weeks prior torandomization.
3. Known intolerance to any ESA, parenteral iron supplementation, or PEGylatedmolecule.
4. Known hematological disease (including but not limited to myelodysplasticsyndrome, hematological malignancy, hemoglobinopathy, pure red cell aplasia,hemolytic syndromes, coagulation disorder, etc.) or cause of anemia other thanrenal disease（e.g. gastrointestinal bleeding or hookworm disease for stool occultblood positive，etc.）.
5. Known autoimmune diseases（e.g. rheumatoid arthritis, systemic lupuserythematosus, anti-neutrophil cytoplasmic antibody related vasculitis, etc.）.
6. Obvious infection occurred within 4 weeks prior to randomization，perinvestigator's clinical judgment.
7. Chronic, uncontrolled, or symptomatic inflammatory disease，per investigator'sclinical judgment.
8. Uncontrolled or symptomatic secondary hyperparathyroidism，per investigator'sclinical judgment.
9. Poorly controlled hypertension within 4 weeks prior to randomization, perinvestigator's clinical judgment.
10. Chronic congestive heart failure (New York Heart Association Class III~IV).
11. Active hepatitis or any of the following check exceptions: ALT≥ 2 × upper limitof normal (ULN), AST≥ 2 × upper limit of normal (ULN), DBIL≥ 2 × upper limit ofnormal (ULN).
12. A positive test for HIV antibody.
13. Tumor malignancy（non-melanoma skin cancer and carcinoma in situ that have beenresected are excluded）.
14. Significant symptoms or diseases within 6 months prior to randomization，and theinvestigator judged that these diseases or symptoms may affect evaluation orfollow-up.
15. Expected survival less than 12 months.
16. Planed to participate in a kidney transplant or have a kidney donor during thetrial.
17. Elective surgery during the study.
18. Expected conception within 4 weeks after the end of the study treatment.
19. The subject has participated in other clinical trial within the 12 weeks prior torandomization and throughout the trial period.
20. Have any other condition or prior therapy that, in the investigator's opinion,would make the subject unsuitable for the study, or unable or unwilling to complywith the study procedures.