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Real-World Research on Efficacy of Enarodustat in Patients With CKD-Associated Anemia

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Observational

SUMMARY

This is a single-center, prospective real-world observational study aiming to evaluate the efficacy and safety of oral enarodustat in adult non-dialysis chronic kidney disease (ND-CKD) patients with renal anemia. A total of 90 eligible participants will be enrolled and stratified into three groups according to baseline C-reactive protein (CRP) levels: CRP ≤3 mg/L, 3\<CRP ≤10 mg/L, and CRP\>10 mg/L. All subjects receive routine oral enarodustat treatment with individualized dose titration, together with standard supportive care for CKD. Each participant will be followed up every 4 weeks for a total of 24 weeks. The primary objective is to compare the change in hemoglobin from baseline to week 24 across different inflammation subgroups. Secondary objectives include analyzing dynamic changes of iron metabolism indicators and documenting all adverse events during treatment. This study will explore the optimal individualized dosing strategy of enarodustat under different inflammatory and iron status.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 85

Healthy Volunteers: f

View:

• Aged 18-85 years, male or female;

• CKD-EPI eGFR \<60 mL/min/1.73m², stage 3-5 non-dialysis chronic kidney disease;

• Baseline hemoglobin ≥70 g/L and \<110 g/L, diagnosed with CKD-associated anemia;

• No plan for dialysis or kidney transplant within 24 weeks;

• Voluntary participation and signed written informed consent.

Locations

Other Locations

China

Huashan hospital, Fudan university

RECRUITING

Shanghai

Contact Information

Primary

Mengjing Wang, PhD, MD

fiyona27@126.com

02152889393

Backup

Jing Chen, PhD, MD

Time Frame

Start Date: 2025-03-23

Estimated Completion Date: 2027-12-31

Participants

Target number of participants: 90

Treatments

Normal inflammation group (CRP ≤3 mg/L)

Participants with baseline serum CRP ≤3 mg/L. All subjects receive oral enarodustat, initial dose 4 mg once daily, with dose adjusted between 1-8 mg every 4 weeks to maintain hemoglobin 110-130 g/L. Standard CKD supportive therapy and iron supplementation will be provided if iron deficiency exists.

Mild inflammation group (3<CRP ≤10 mg/L)

Participants with baseline serum CRP greater than 3 mg/L and ≤10 mg/L. All subjects receive oral enarodustat, initial dose 4 mg once daily, with dose adjusted between 1-8 mg every 4 weeks to maintain hemoglobin 110-130 g/L. Standard CKD supportive therapy and iron supplementation will be provided if iron deficiency exists.

Moderate inflammation group (CRP>10 mg/L)

Participants with baseline serum CRP\>10 mg/L. All subjects receive oral enarodustat, initial dose 4 mg once daily, with dose adjusted between 1-8 mg every 4 weeks to maintain hemoglobin 110-130 g/L. Standard CKD supportive therapy and iron supplementation will be provided if iron deficiency exists.

Related Therapeutic Areas

Anemia

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