Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
28 de julho de 2026 atualizado por: Chen Jing, Huashan Hospital
Real-World Research on Efficacy of Enarodustat in Patients With CKD-Associated Anemia
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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Estimado)
90
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Mengjing Wang, PhD, MD
- Número de telefone: 02152889393
- E-mail: fiyona27@126.com
Estude backup de contato
- Nome: Jing Chen, PhD, MD
Locais de estudo
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200040
- Recrutamento
- Huashan Hospital, Fudan University
-
Contato:
- Mengjing Wang Huashan hospital, Fudan university, PhD, MD
- Número de telefone: 021-52889393
- E-mail: fiyona27@126.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in hemoglobin (Hb) from baseline to Week 24
Prazo: 24 weeks after enrollment
|
Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.
|
24 weeks after enrollment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hemoglobin control rate at each follow-up visit
Prazo: Week 4, 8, 12, 16, 20, 24
|
Proportion of participants achieving target hemoglobin (110-130 g/L) at Week 4, 8, 12, 16, 20, 24
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Week 4, 8, 12, 16, 20, 24
|
|
Hemoglobin rising rate within the first 4 weeks
Prazo: Baseline to Week 4
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Average Hb increase rate (g/L per month) during the first 4 weeks of treatment, stratified by baseline CRP and ferritin
|
Baseline to Week 4
|
|
Changes in iron metabolism and inflammatory biomarkers
Prazo: Week 12, Week 24
|
Changes of ferritin, TSAT, serum iron, hepcidin and CRP from baseline to Week 12 and Week 24
|
Week 12, Week 24
|
|
Dynamic changes of routine blood parameters
Prazo: Week 4, 8, 12, 16, 20, 24
|
Changes in RBC, Hct, MCV, RDW at each 4-week follow-up
|
Week 4, 8, 12, 16, 20, 24
|
|
Incidence of adverse events and serious adverse events
Prazo: Baseline to Week 24
|
Proportion of participants experiencing any adverse event (AE) or serious adverse event (SAE) during the 24-week observation period
|
Baseline to Week 24
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jing Chen, PhD, MD, Huashan Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de março de 2025
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
28 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de julho de 2026
Primeira postagem (Real)
3 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KY-2024-1391
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano IPD
Data will be made available upon request pending
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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