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โ† Trials
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Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients

Recruitingn/aAges 18 Years - 85 YearsAllHuashan Hospital
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In plain words

What the trial is, and whether it could suit you

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 โ‰ค3 mg/L, 3\<CRP โ‰ค10 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 e

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18-85 years, male or female; 2. CKD-EPI eGFR \<60 mL/min/1.73mยฒ, stage 3-5 non-dialysis chronic kidney disease; 3. Baseline hemoglobin โ‰ฅ70 g/L and \<110 g/L, diagnosed with CKD-associated anemia; 4. No plan for dialysis or kidney transplant within 24 weeks; 5. Voluntary participation and signed written informed consent. Exclusion Criteria: 1. Severe infection, acute kidney injury, myocardial infarction, stroke, decompensated heart failure within recent 3 months; 2. Malignancy, severe liver dysfunction (AST/ALT\>2.5 ULN, total bilirubin\>1.5 ULN), multiple organ failure; 3. Autoimmune disease (lupus, vasculitis, rheumatoid arthritis) or chronic persistent infection (tuberculosis, fungal infection); 4. Pregnant or breastfeeding women; 5. Other causes of anemia (aplastic anemia, myelodysplastic syndrome, hemolytic anemia, active gastrointestinal bleeding); 6. Poor compliance judged by investigator, unable to complete scheduled follow-up.
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What it tests

  • Enarodustat
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Where

1 site
Huashan hospital, Fudan university
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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