Chinese chronic kidney disease anemia patients undergoing hemodialysis
Conditions
Interventions
Experimental group:The experimental drug rhEPO-Fc was administered
Control group:Give Reserx
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Must meet to be included in the group: 1. Patients with chronic renal failure received adequate maintenance hemodialysis for more than 12 weeks before inclusion, and dialysis treatment was performed 2-4 times per week; 2. Chinese citizens, 18-75 years old (including boundary values); 3. No gender limitation; 4. The patients were receiving ESAs treatment for at least 12 weeks before inclusion, and the average weekly dose was less than 10,000 IU; 5. Within 6 weeks of the screening period, the detection value of hemoglobin should be within 100~120g/L (including the threshold value) for the last two times before randomization, and the detection time should be at least 7 days apart; 6. The serum folic acid value and vitamin B12 level of the subjects before inclusion were = the lower limit of normal value; 7. For hemodialysis subjects, the catheter should be used in three other channels except temporary catheter; 8. The subjects voluntarily participate in the experiment and sign the informed consent, and can complete the study in accordance with the experimental protocol.
Exclusion criteria
Exclusion criteria: One is excluded: 1. Blood pressure was not effectively controlled before inclusion (diastolic blood pressure > 110 mmHg or systolic blood pressure > 170 mmHg); 2. Patients with refractory hypertension prior to enrollment (refractory hypertension who could not control blood pressure at the target level after several weeks of adequate treatment with non-drug therapy and at least 3 drugs including diuretics); 3. Known cerebrovascular malformations (such as cerebral hemangioma); 4. Previous or current malignant tumors (except resected non-melanoma skin cancer and carcinoma in situ); 5. Patients suffering from NYHA Class III or IV heart failure, or with ECG showing QTc interval = 550ms; 6. History of severe liver disease; 7. ALT or AST exceeded the upper limit of normal value by 2 times before inclusion; 8. Patients who had received immunosuppressive therapy within 3 months before enrollment; 9. Participated in other drug clinical trials within 3 months or medical device clinical trials within 1 month before admission; 10. Patients who are in the acute stage of thromboembolic disease; 11. Known blood clotting disorder or hemolysis; 12. Have uncontrolled chronic immune diseases (e.g. Rheumatoid arthritis, systemic lupus erythematosus, etc.); 13. Significant infection or C-reactive protein = 30mg/L occurred; 14. Patients in the active stage of tuberculosis; 15. Pregnant and lactating women; 16. Patients with a history of gastrointestinal bleeding, massive bleeding or blood transfusion within 3 months before screening; 17. Serum ferritin < of subjects before enrollment; 100µg/L and transferrin saturation < 20%; 18. iPTH > of pre-enrolled subjects; 800pg/mL; 19. Persons who combine the use of aluminum preparations in the three months prior to screening, or who are engaged in work that may lead to the accumulation of aluminum in the body; 20. Patients who have a clear history of allergy to excipients of ESAs or rhEPO-Fc preparations, or who have been determined by the nvestigator to be potentially allergic to this product; 21. Patients who are taking antipsychotic drugs; 22. Life expectancy of less than 12 months; 23. Subjects determined by the investigator to be unsuitable candidates for the study (medical conditions that the investigator believes may pose a threat to the safety of subjects participating in the study, medical conditions that may confuse efficacy or safety evaluations, or medical conditions that may interfere with the subject's participation in the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of mean hemoglobin from baseline during W21 to W28.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes of hemoglobin values at each site during W1~W28 compared with baseline values;;2. The proportion of subjects whose hemoglobin values remained ±10g/L from baseline during W21 to W28;;3. Proportion of subjects with a hemoglobin value of [100,120]g/L during W21 to W28;4. The number of dose adjustments (increase or decrease) and the proportion of subjects during W1~W28.; | — |
Countries
China
Contacts
Public ContactZuo li
Peking University People's Hospital
Outcome results
None listed