Clinical Research Directory

Inclusion Criteria: 1. Aged 18-75 years at the time of consent to participate; 2. Body weight ranged from 45 to 100 kg; 3. Diagnosed with CKD stages 2-5 (10 ≤ eGFR \< 90 mL/min/1.73m2) and were not dialysis dependent; 4. Diagnosed with renal anemia: 1)Hemoglobin level of 6 - 10 g/dL for those who have not received ESA or HIF-PHI treatment within 6 weeks at screening; 2)Hemoglobin level of 8 - 12 g/dL for those who are currently receiving ESA (ESA dosage ≤ 10,000 IU/week) or HIF-PHI (roxadustat dosage≤ 100 mg TIW) at screening; 5. Serum ferritin \> 100 μg/L or transferrin saturation \> 20% at screening; 6. Voluntary participation in the trial and signing of the informed consent form. Exclusion Criteria: 1. Uncontrolled hypertension identified as systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg after 4 weeks of regular and adequate drug therapy prior to screening; 2. Uncontrolled proteinuria identified as UACR \>3000mg/g or 24-hour urine protein \>3.5g in non-diabetic patients and UACR of \>5000mg/g or 24-hour urine protein \>5.5g in diabetic patients; 3. Anemia due to other reasons except CKD including systemic hematological disorders (such as myelodysplastic syndrome, aplastic anemia, etc.), hemolytic anemia, hemorrhagic anemia or cancer-related anemia; 4. History of autoimmune diseases which could result in anemia such as systemic lupus erythematosus and ANCA vasculitis; 5. History of active bleeding within 4 weeks prior to screening; 6. History of serious thrombotic event such as a myocardial infarction, cerebral infarction, pulmonary embolism, unstable angina, or PCI or cardiac surgery within 6 months prior to screening; 7. Severe heart failure (NYHA class IV) at screening; 8. History of blood transfusion within 2 months prior to screening; 9. History of usage of immunosuppressants or other immune therapies within 6 months prior to screening; 10. Patients who are estimated to require dialysis, kidney transplantation, or major surgery within 6 months; 11. Severe liver and biliary system complications (AST or ALT \>3 times the upper limit of normal, total bilirubin \>2 times the upper limit of normal) at screening; 12. Receiving ESA combined with roxadustat treatment at screening; 13. History of proliferative retinopathy or diabetic retinopathy requiring ophthalmological treatment; 14. Severe hyperparathyroidism (iPTH ≥ 500 pg/mL); 15. Severe active infections (such as active tuberculosis, fungal infections, etc.); 16. Patients who are bedridden or have difficulty walking, or have a history of atrial fibrillation or deep vein thrombosis of the lower limbs; 17. History of active tumors; 18. Female patients who are pregnant or breastfeeding, or non-childbearing women who do not agree to effective contraception; 19. Patients with a history of severe drug allergies (such as anaphylactic shock), or known allergies to any of the active ingredients or excipients of enarodostat; 20. Patients who are currently participating in any other interventional clinical trial; 21. Other reasons determined by the investigator not suitable for participation in the study.