Stage 5 Chronic Kidney Disease
Conditions
Interventions
ESAs group:None
Sponsors
The Second Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years. 2.Undergoing maintenance hemodialysis (MHD) for no less than 3 months. 3.Meeting the diagnostic criteria for ESA hyporesponsiveness: under sufficient iron status, maintenance hemodialysis patients presented with hemoglobin (Hb) < 110 g/L or an Hb increment < 10 g/L after 4 consecutive weeks of adequate-dose recombinant human erythropoietin (rHuEPO) treatment. Confounding factors affecting anemia including infection, inflammation, secondary hyperparathyroidism, malnutrition, bleeding and aluminum accumulation were excluded. 4.Willing to switch to or initiate Pegmolesatide treatment. 5.Voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Active bleeding, severe infection, or uncontrolled malignancy; 2. Major surgery or blood transfusion within the past 3 months; 3. Known hypersensitivity to pegmolesatide or any of its excipients; 4. Pregnancy or lactation; 5.Other conditions deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin achievement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin;Magnitude of Hb elevation from baseline;Hb response rate;Individual dose coefficient of variation; | — |
Countries
China
Contacts
Public ContactJie Liu
The Second Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed