Enarodustat+CsA vs CsA in the Treatment of Newly-diagnosed TD-NSAA
Reason given: The registration of this research plan was incorrect. A new registration has been re-applied for.
Key facts
- Phase
- Phase 3
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07522996
- Record updated
- 4 June 2026
- Original description
This study aimed to compare the efficacy and safety of enarodustat combined with cyclosporine versus cyclosporine alone in the treatment of TD-NSAA.Read full original descriptionShow less
Enarodustat Plus CsA Versus CsA Monotherapy in the Treatment of Newly-diagnosedTD-NSAA: a Single-center Randomized Trial
This study aimed to compare the efficacy and safety of enarodustat combined with cyclosporine versus cyclosporine alone in the treatment of TD-NSAA.
Inclusion: Age ≥ 18 years old; 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; Had no HLA-matched donors or was not suitable for first-line allogeneic hematopoietic stem cell transplantation (HSCT); With baseline liver and kidney functions <2 ULN; ECOG score ≤ 2; Signed the informed consent.
Exclusion: Received HSCT before enrollment; Previously used immunosuppressive treatments such as ATG, CsA, TPO receptor agonists (TPO-RAs), roxadustat; Had other primary or secondary bone marrow failure (BMF) diseases, such as Fanconi anemia, congenital keratinization disorder, etc; With evidence of clonal hematological bone marrow diseases (MDS, AML) in cytogenetics; Allergic or intolerant to enarodustat or CsA; Severe bleeding or infection that cannot be controlled by standard treatment; Complicated with malignant tumors; PNH clone ≥ 50%; Pregnant or lactating patients; Participated in other clinical trials within 3 months; Patients considered not suitable to participate in this study by the investigator.