Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
28 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
90
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Mengjing Wang, PhD, MD
- Numéro de téléphone: 02152889393
- E-mail: fiyona27@126.com
Sauvegarde des contacts de l'étude
- Nom: Jing Chen, PhD, MD
Lieux d'étude
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200040
- Recrutement
- Huashan Hospital, Fudan University
-
Contact:
- Mengjing Wang Huashan hospital, Fudan university, PhD, MD
- Numéro de téléphone: 021-52889393
- E-mail: fiyona27@126.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in hemoglobin (Hb) from baseline to Week 24
Délai: 24 weeks after enrollment
|
Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.
|
24 weeks after enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hemoglobin control rate at each follow-up visit
Délai: 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
|
Week 4, 8, 12, 16, 20, 24
|
|
Hemoglobin rising rate within the first 4 weeks
Délai: Baseline to Week 4
|
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
Délai: 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
Délai: 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
Délai: 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
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jing Chen, PhD, MD, Huashan Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
23 mars 2025
Achèvement primaire (Estimé)
31 décembre 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
28 juillet 2026
Première soumission répondant aux critères de contrôle qualité
28 juillet 2026
Première publication (Réel)
3 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KY-2024-1391
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
Data will be made available upon request pending
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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