Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
28. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
90
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mengjing Wang, PhD, MD
- Telefonnummer: 02152889393
- E-mail: fiyona27@126.com
Undersøgelse Kontakt Backup
- Navn: Jing Chen, PhD, MD
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200040
- Rekruttering
- Huashan Hospital, Fudan University
-
Kontakt:
- Mengjing Wang Huashan hospital, Fudan university, PhD, MD
- Telefonnummer: 021-52889393
- E-mail: fiyona27@126.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in hemoglobin (Hb) from baseline to Week 24
Tidsramme: 24 weeks after enrollment
|
Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.
|
24 weeks after enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hemoglobin control rate at each follow-up visit
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jing Chen, PhD, MD, Huashan Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. marts 2025
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
28. juli 2026
Først indsendt, der opfyldte QC-kriterier
28. juli 2026
Først opslået (Faktiske)
3. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KY-2024-1391
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Data will be made available upon request pending
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