Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients | NCT07741279

NCT07741279

Overview

NCT ID: NCT07741279
Lead Sponsor: Huashan HospitalOTHER
Official Title: Real-World Research on Efficacy of Enarodustat in Patients With CKD-Associated Anemia
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Mar 23, 2025Actual
Primary Completion Date: Dec 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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 Criteria:

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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 90Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Mengjing Wang, PhD, MDContact
fiyona27@126.com02152889393

Similar Studies

Participant Group/Arms

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.

Drug: Enarodustat

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.

Drug: Enarodustat

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.

Drug: Enarodustat