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Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA

ConditionTransfusion-dependent Non-severe Aplastic Anemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enarodustat

    Drug

    Enarodustat 8mg qd

  • Cyclosporine (CsA)

    Drug

    CsA 3-5mg/kg/d, trough concentration 100-200ng/ml

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: CsA+EnarodustatExperimental treatment 2 interventions
Group B: CsAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ORR

ORR=CRR+PRR

Time frame
6-month

Secondary outcomes

1

ORR

ORR=CRR+PRR

Time frame
3-month, 12-month
2

RBC-TI rate

Proportion of patients who achieve red blood cell transfusion independence for 8 weeks or longer

Time frame
3-month, 6-month, 12-month
3

hemoglobin response rate

Proportion of patients with hemoglobin response

Time frame
3-month, 6-month, 12-month
4

AE rate

According to CTCAE, the proportion of patients with adverse events (AEs)

Time frame
through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: