Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA

This study aimed to compare the efficacy and safety of enarodustat combined with cyclosporine versus cyclosporine monotherapy in the treatment of newly-diagnosed tansfusion-dependent non-severe aplastic anemia (TD-NSAA).

Inclusion Criteria: 1. Age ≥ 18 years old; 2. Diagnosed with aplastic anemia (AA) through routine blood tests, bone marrow puncture, bone marrow biopsy, and exclusion tests, and determined as transfusion-dependent non-severe aplastic anemia (TD NSAA) according to the Camitta criteria; Hemoglobin\<90g/L; 3. Had no HLA-matched donors or was not suitable for first-line allogeneic hematopoietic stem cell transplantation (HSCT); 4. With baseline liver and kidney functions \<2 ULN; 5. ECOG score ≤ 2; 6. Signed the informed consent; Exclusion Criteria: 1. Had other primary or secondary bone marrow failure (BMF) diseases, such as Fanconi anemia, congenital keratinization disorder, etc.; 2. With evidence of clonal hematological bone marrow diseases (MDS, AML) in cytogenetics; 3. PNH clone ≥ 50%; 4. Received HSCT before enrollment; 5. Previously used immunosuppressive treatments such as ATG, CsA, TPO receptor agonists (TPO-RAs), roxadustat; 6. Allergic or intolerant to enarodustat or CsA; 7. Pregnant or lactating patients; 8. Severe bleeding or infection that cannot be controlled by standard treatment; 9. Complicated with malignant tumors; 10. Participated in other clinical trials within 3 months; 11. Patients considered not suitable to participate in this study by the investigator.