Renal Anemia
Conditions
Interventions
Pegmolesatide standard regimen group:a. Initial dose: 0.04mg/kg body weight, once a month, subcutaneous injection.
b. Dose adjustment: once a month, each time according to the patients Hb level and th
Pegmolesatide optimized regimen group:a. Initial dose: weight 60Kg, 3.2mg
Once a month, subcutaneous injection.
b. Dose adjustment: The dose of pemoxatide is determined once a month according to the patients Hb level and Hb change relative to the previous follow-up (?Hb) (m
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Eligible subjects who meet all criteria: 1. Age >=18 years old, and = 45kg and body mass index (BMI) >=18.5kg/m2; 3. CKD was diagnosed according to KDIGO guidelines, non-dialysis dependent CKD population definition: The estimated glomerular filtration rate (eGFR) before enrollment was >=15mL/min/1.73m2 and = 1.2 for hemodialysis and Kt/V >= 1.7 for peritoneal dialysis; 5. At least 2 visits/follow-up visits in the study center within the past 24 weeks; 6. Before randomization, the Hb value of 60g/L=200 ng/mL in hemodialysis patients during screening period; Serum folate level = lower limit of normal value, vitamin B12>= lower limit of normal value; 8. Understand the study procedures and voluntarily sign the Informed Consent form (ICF) in person.
Exclusion criteria
Exclusion criteria: Subjects were excluded if they had any of the following conditions: 1. Known active malignancy *, autoimmune disease, hematologic disease (both congenital and acquired), Such as thalassemia, Fanconi anemia, pure red cell aplastic anemia, myelodysplastic syndrome, hemolytic anemia and coagulopathy, etc.) (see the text of the protocol for details on the criteria for coagulopathy) or other causes of anemia except CKD (such as gastrointestinal bleeding or hookworm disease, etc.); 2. Stroke, transient ischemic attack, myocardial infarction, thromboembolism (deep vein thrombosis), and pulmonary embolism in the past 6 months; 3. Hypoproteinemia (serum albumin =30mg/L within 3 days before randomization; 10. Pregnant, lactating women, women of childbearing age with a positive urine ß-HCG test before the test, or those who planned to become pregnant during the study; 11. Planned kidney transplantation during the trial period or existing kidney donors; 12. Patients scheduled for elective surgery during the trial; 13. Subjects with any other factors considered by the investigator to be ineligible for the trial, such as poorly controlled blood pressure. Active malignant tumors * : active malignant tumors should be excluded; However, patients with inactive malignancy could be enrolled if they had not received surgery, radiotherapy or chemotherapy in the last 3 years and had no evidence of recurrence at present.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in mean hemoglobin (Hb) levels from baseline at week 24 of the treatment period in the standard regimen group and the optimized regimen group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of mean Hb levels from baseline in the two groups at week 48 of the treatment period;Changes in Hb from baseline at each follow-up point between the two groups;The median time to first achieve the target hemoglobin (Hb) levels (defined as: 110 g/L <= Hb <= 130 g/L) in two groups.;The proportion of participants with Hb target achieved at each follow-up visit in both groups.;Changes in Hb, red blood cell count, and hematocrit from baseline at each follow-up point between the two groups.;The average dose of medication for Hb-targeted participants at each follow-up point in both groups.;The cumulative dose adjustment times for the 24-week and 48-week groups of subjects; | — |
Countries
China
Contacts
Public ContactDing Xiaoqiang
Zhongshan Hospital Fudan University
Outcome results
None listed