Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorHuashan Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Adult non-dialysis chronic kidney disease patients complicated with renal anemia who receive enarodustat treatment. Subjects are stratified by baseline CRP levels to evaluate treatment efficacy and safety.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Enarodustat
DrugOral 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Normal inflammation group (CRP ≤3 mg/L)1 intervention
Group B: Mild inflammation group (3<CRP ≤10 mg/L)1 intervention
Group C: Moderate inflammation group (CRP>10 mg/L)1 intervention
Trial outcomes
Primary outcomes
1
Change in hemoglobin (Hb) from baseline to Week 24
Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.
Time frame
24 weeks after enrollmentSecondary outcomes
1
Hemoglobin control rate at each follow-up visit
Proportion of participants achieving target hemoglobin (110-130 g/L) at Week 4, 8, 12, 16, 20, 24
Time frame
Week 4, 8, 12, 16, 20, 242
Hemoglobin rising rate within the first 4 weeks
Average Hb increase rate (g/L per month) during the first 4 weeks of treatment, stratified by baseline CRP and ferritin
Time frame
Baseline to Week 43
Changes in iron metabolism and inflammatory biomarkers
Changes of ferritin, TSAT, serum iron, hepcidin and CRP from baseline to Week 12 and Week 24
Time frame
Week 12, Week 244
Dynamic changes of routine blood parameters
Changes in RBC, Hct, MCV, RDW at each 4-week follow-up
Time frame
Week 4, 8, 12, 16, 20, 24Sponsors and contacts
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Source ClinicalTrials.gov