Enarodustat for Anemia in Non-Dialysis CKD Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective observational study enrolling 90 adults with CKD-related anemia who are not on dialysis. All participants receive oral enarodustat with dose adjustments every 4 weeks over 24 weeks, plus standard CKD care and iron supplementation as needed. Participants are stratified into three inflammation groups based on baseline CRP (≤3 mg/L, 3–10 mg/L, >10 mg/L) to see if inflammation affects Hb response and iron markers. Primary endpoint is change in hemoglobin from baseline to week 24; secondary endpoints include Hb target achievement, speed of Hb rise, and safety with adverse events tracking. Extended biomarkers are measured at baseline, week 12, and week 24 to characterize iron, inflammatory, and metabolic parameters. This study also explores personalized dosing of enarodustat across inflammatory and iron-status backgrounds.

Why it matters

Who can join: the full rules

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.

Where it's running

• Huashan hospital, Fudan university
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jing Chen, PhD, MD — Huashan Hospital
• Study coordinator: Mengjing Wang, PhD, MD
• Email: fiyona27@126.com
• Phone: 02152889393

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.