Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA
Starting soon · Phase 3
Conditions studied: Transfusion-dependent Non-severe Aplastic Anemia
In brief
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).
Key facts
- Study ID
- NCT07548671
- Run by
- Peking Union Medical College Hospital
- People needed
- 90
- Starts
- 2026-04-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
- PNH clone ≥ 50%;
- Received HSCT before enrollment;
- Previously used immunosuppressive treatments such as ATG, CsA, TPO receptor agonists (TPO-RAs), roxadustat;
- Allergic or intolerant to enarodustat or CsA;
- Pregnant or lactating patients;
- Severe bleeding or infection that cannot be controlled by standard treatment;
- Complicated with malignant tumors;
- Participated in other clinical trials within 3 months;
- Patients considered not suitable to participate in this study by the investigator.
Full record on ClinicalTrials.gov
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