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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Enarodustat for people with anemia of chronic kidney disease, ckd, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

Huashan hospital, Fudan university

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07741279


Related Trials