NCT07741279Recruiting
Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
Real-World Research on Efficacy of Enarodustat in Patients With CKD-Associated Anemia
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 23 Mar 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Huashan Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07741279
What you commit to
- Study type: Observational
- Planned participants: 90
- From 23 Mar 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Lab values
- Malignancy, severe liver dysfunction (AST/ALT\>2.5 ULN, total bilirubin\>1.5 ULN), multiple organ failure;
Other
- Pregnant or breastfeeding women;
- Poor compliance judged by investigator, unable to complete scheduled follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.