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RECRUITING
NCT07741279

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

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

DRUG

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