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

Официальное название

Real-World Research on Efficacy of Enarodustat in Patients With CKD-Associated Anemia

Обзор

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.

Подробное описание

Enarodustat is an oral HIF-PHI that elevates endogenous EPO to treat CKD-related anemia. Inflammation and iron disturbance interfere with its efficacy, while real-world stratified data for Chinese non-dialysis CKD patients remain scarce.

This single-center prospective cohort will recruit 90 patients equally divided into 3 groups by baseline CRP: normal (CRP ≤3 mg/L), mild inflammation (3\<CRP ≤10 mg/L), moderate inflammation (CRP\>10 mg/L). All subjects start enarodustat 4 mg qd, with dose adjusted 1-8 mg every 4 weeks to keep Hb 110-130 g/L. Iron supplements will be given for iron deficiency, and routine CKD medications stay stable.

Participants attend 6 visits over 24 weeks. Blood tests are performed every 4 weeks. Extended biomarkers tested at baseline, Week12 and Week24 include CBC, reticulocyte count, folate, vitamin B12, EPO, renal function, electrolytes, iPTH, iron profiles, hepcidin and CRP. UACR, vital signs, medication records, drug dose logs and all adverse events are recorded at each visit.

Primary endpoint: Hb change from baseline to Week24. Secondary endpoints cover Hb target control rate, early Hb elevation speed, longitudinal changes of reticulocytes, renal, electrolyte, bone mineral, nutritional, iron and inflammatory markers, plus total adverse event incidence. This study explores personalized enarodustat dosing under different inflammatory, iron and metabolic backgrounds.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Change in hemoglobin (Hb) from baseline to Week 24 [Срок оценки: 24 weeks after enrollment]

Вторичные конечные точки (5)

• Hemoglobin control rate at each follow-up visit [Срок оценки: Week 4, 8, 12, 16, 20, 24]
• Hemoglobin rising rate within the first 4 weeks [Срок оценки: Baseline to Week 4]
• Changes in iron metabolism and inflammatory biomarkers [Срок оценки: Week 12, Week 24]
• Dynamic changes of routine blood parameters [Срок оценки: Week 4, 8, 12, 16, 20, 24]
• Incidence of adverse events and serious adverse events [Срок оценки: Baseline to Week 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Huashan hospital, Fudan university — Шанхай

Идентификаторы

NCT: NCT07741279 · KY-2024-1391

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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