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Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
Sponsor: Huashan Hospital
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.
Official title: Real-World Research on Efficacy of Enarodustat in Patients With CKD-Associated Anemia
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
OBSERVATIONAL
Enrollment
90
Start Date
2025-03-23
Completion Date
2027-12-31
Last Updated
2026-08-03
Healthy Volunteers
No
Interventions
Enarodustat
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.
Locations (1)
Huashan hospital, Fudan university
Shanghai, Shanghai Municipality, China