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Not yet recruiting NCT07548671

Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA

Phase III Interventional Transfusion-dependent Non-severe Aplastic Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enarodustat, Cyclosporine (CsA).
Who it may be relevant to
Registry conditions: Transfusion-dependent Non-severe Aplastic Anemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Enarodustat Combined With Cyclosporine Versus Cyclosporine Monotherapy in the Treatment of Newly Diagnosed TD-NSAA

Overview

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).

Interventions

  • Drug Enarodustat
    Enarodustat 8mg qd
  • Drug Cyclosporine (CsA)
    CsA 3-5mg/kg/d, trough concentration 100-200ng/ml

Primary outcome measures

  • ORR [Time frame: 6-month]
Secondary outcome measures (4)
  • ORR [Time frame: 3-month, 12-month]
  • RBC-TI rate [Time frame: 3-month, 6-month, 12-month]
  • hemoglobin response rate [Time frame: 3-month, 6-month, 12-month]
  • AE rate [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07548671 · K10247

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗