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

28 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

90

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Mengjing Wang, PhD, MD
  • Telefoonnummer: 02152889393
  • E-mail: fiyona27@126.com

Studie Contact Back-up

  • Naam: Jing Chen, PhD, MD

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Werving
        • Huashan Hospital, Fudan University
        • Contact:
          • Mengjing Wang Huashan hospital, Fudan university, PhD, MD
          • Telefoonnummer: 021-52889393
          • E-mail: fiyona27@126.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  1. Aged 18-85 years, male or female;
  2. CKD-EPI eGFR <60 mL/min/1.73m², stage 3-5 non-dialysis chronic kidney disease;
  3. Baseline hemoglobin ≥70 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Geneesmiddel: 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.
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.
Geneesmiddel: 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.
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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in hemoglobin (Hb) from baseline to Week 24
Tijdsspanne: 24 weeks after enrollment
Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.
24 weeks after enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hemoglobin control rate at each follow-up visit
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Huashan Hospital

Onderzoekers

  • Hoofdonderzoeker: Jing Chen, PhD, MD, Huashan Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 maart 2025

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

28 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juli 2026

Eerst geplaatst (Werkelijk)

3 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

28 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KY-2024-1391

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Data will be made available upon request pending

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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