Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA | NCT07548671

Studies
Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA

NCT07548671

Sponsor

Peking Union Medical College Hospital

Status

Not yet recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

90Estimated

Phase

Phase 3

Conditions

Transfusion-dependent Non-severe Aplastic Anemia

Interventions

Enarodustat
Cyclosporine (CsA)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Apr 16, 2026

First Submission Date that Met QC Criteria

Apr 16, 2026

First Posted Date

Apr 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CsA+Enarodustat	Experimental	CsA 3-5mg/kg/d Enarodustat 8mg qd	Drug: Enarodustat Drug: Cyclosporine (CsA)
CsA	Active Comparator	CsA 3-5mg/kg/d	Drug: Cyclosporine (CsA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enarodustat	Drug	Enarodustat 8mg qd	CsA+Enarodustat
Cyclosporine (CsA)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR	ORR=CRR+PRR	6-month

Secondary Outcomes

Measure	Description	Time Frame
ORR	ORR=CRR+PRR	3-month, 12-month
RBC-TI rate	Proportion of patients who achieve red blood cell transfusion independence for 8 weeks or longer

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Bing Han	Contact	+86 13601059938		hanbing_li@sina.com.cn

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds