NCT07741279 Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
| NCT ID | NCT07741279 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Anemia of Chronic Kidney Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-03-23 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2025-03-23 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Jing Chen, PhD, MD
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT07741279 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Anemia of Chronic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07741279 currently recruiting?
Yes, NCT07741279 is actively recruiting participants. Contact the research team at fiyona27@126.com for enrollment information.
Where is the NCT07741279 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07741279 clinical trial?
NCT07741279 is sponsored by Huashan Hospital. The principal investigator is Jing Chen, PhD, MD at Huashan Hospital. The trial plans to enroll 90 participants.
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