Enarodustat for anemia in adults with chronic kidney disease not on dialysis
Observes how enarodustat works for anemia in adults with kidney disease.
Plain-language title generated from the registry record
Registry title: Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07741279, who can take part
Where in China
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT07741279
- Record updated
- 3 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Severe infection, acute kidney injury, myocardial infarction, stroke, decompensated heart failure within recent 3 months; Autoimmune disease (lupus, vasculitis, rheumatoid arthritis) or chronic persistent infection (tuberculosis, fungal infection); Other causes of anemia (aplastic anemia, myelodysplastic syndrome, hemolytic anemia, active gastrointestinal bleeding); Malignancy, severe liver dysfunction (AST/ALT>2.5 ULN, total bilirubin>1.5 ULN), multiple organ failure; Pregnant or breastfeeding women; Poor compliance judged by investigator, unable to complete scheduled follow-up.