Anemia of chronic kidney disease
Conditions
Interventions
Enarodustat treatment group:Enarodustat
rHuEPO treatment group:rHuEPO
Sponsors
363 Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years (both sexes, body weight 45–80 kg); 2. On stable maintenance hemodialysis or hemodiafiltration for at least 16 weeks (three sessions per week, 4 hours per session); 3. Receiving a stable dose of erythropoiesis-stimulating agent (ESA) for >3 months prior to enrollment, with a weekly EPO dose of 750–15,000 IU; 4. Mean hemoglobin between 90 g/L and 120 g/L, transferrin saturation (TSAT) >20% or serum ferritin >75 ng/mL; 5. Long-term regular hemodialysis at the hemodialysis center of our hospital; 6. Willing to participate and provide written informed consent; 7. Not currently enrolled in any other clinical study that conflicts with the present trial.
Exclusion criteria
Exclusion criteria: 1. Anemia due to other causes or concurrent active bleeding; 2. Presence of other serious diseases, including malignancy, severe infection, or liver cirrhosis; or a history of acute cardiovascular or cerebrovascular events, or venous thromboembolism (pulmonary embolism or deep vein thrombosis) within 24 weeks prior to screening; 3. Parathyroid hormone level >=500 pg/mL; 4. Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin;Incidence of adverse events and safety assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| microinflammatory factors;electrolytes;lipid metabolism parameters;parathyroid hormone ; | — |
Countries
China
Contacts
Public ContactZhu Dan
Department of Nephrology, 363 Hospital
Outcome results
None listed