RecruitingNCT07741279

Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients

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

Sponsor

Huashan Hospital

Enrollment

90 participants

Start Date

Mar 23, 2025

Study Type

OBSERVATIONAL

Conditions

CKD Anemia of Chronic Kidney Disease Non-dialysis Chronic Kidney Disease

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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.

Exclusion Criteria6

Severe infection, acute kidney injury, myocardial infarction, stroke, decompensated heart failure within recent 3 months;
Malignancy, severe liver dysfunction (AST/ALT>2.5 ULN, total bilirubin>1.5 ULN), multiple organ failure;
Autoimmune disease (lupus, vasculitis, rheumatoid arthritis) or chronic persistent infection (tuberculosis, fungal infection);
Pregnant or breastfeeding women;
Other causes of anemia (aplastic anemia, myelodysplastic syndrome, hemolytic anemia, active gastrointestinal bleeding);
Poor compliance judged by investigator, unable to complete scheduled follow-up.

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Interventions

DRUGEnarodustat

Oral enarodustat, starting dose 4 mg once daily. Dose can be titrated between 1 mg and 8 mg every 4 weeks to maintain hemoglobin within 110-130 g/L. Iron supplementation will be administered when iron deficiency is confirmed. Conventional chronic kidney disease medications are maintained as routine clinical practice.