Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
28 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Stimato)
90
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Mengjing Wang, PhD, MD
- Numero di telefono: 02152889393
- Email: fiyona27@126.com
Backup dei contatti dello studio
- Nome: Jing Chen, PhD, MD
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200040
- Reclutamento
- Huashan Hospital, Fudan University
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Contatto:
- Mengjing Wang Huashan hospital, Fudan university, PhD, MD
- Numero di telefono: 021-52889393
- Email: fiyona27@126.com
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in hemoglobin (Hb) from baseline to Week 24
Lasso di tempo: 24 weeks after enrollment
|
Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.
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24 weeks after enrollment
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hemoglobin control rate at each follow-up visit
Lasso di tempo: Week 4, 8, 12, 16, 20, 24
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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
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Hemoglobin rising rate within the first 4 weeks
Lasso di tempo: 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
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Baseline to Week 4
|
|
Changes in iron metabolism and inflammatory biomarkers
Lasso di tempo: Week 12, Week 24
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Changes of ferritin, TSAT, serum iron, hepcidin and CRP from baseline to Week 12 and Week 24
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Week 12, Week 24
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|
Dynamic changes of routine blood parameters
Lasso di tempo: Week 4, 8, 12, 16, 20, 24
|
Changes in RBC, Hct, MCV, RDW at each 4-week follow-up
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Week 4, 8, 12, 16, 20, 24
|
|
Incidence of adverse events and serious adverse events
Lasso di tempo: Baseline to Week 24
|
Proportion of participants experiencing any adverse event (AE) or serious adverse event (SAE) during the 24-week observation period
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Baseline to Week 24
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Jing Chen, PhD, MD, Huashan Hospital
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
23 marzo 2025
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
31 dicembre 2027
Date di iscrizione allo studio
Primo inviato
28 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 luglio 2026
Primo Inserito (Effettivo)
3 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KY-2024-1391
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
Data will be made available upon request pending
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .