Abstract: Objective  To evaluate the efficacy and safety of enarodustat in patients with stage 3-5 non-dialysis dependent chronic kidney disease (NDD-CKD) with concurrent renal anemia.  Methods  This retrospective study analyzed clinical data from NDD-CKD stage 3～5 patients with renal anemia treated at the Department of Nephrology, The Affiliated Taizhou People's Hospital of Nanjing Medical University between June 1, 2024 and February 1 2025. Serial laboratory parameters were compared before and after treatment, and adverse events were systematically documented.  Results  The study included 89 patients (69±10 years old, 39 males) with NDD-CKD stage 3～5 combined with renal anemia. After 4～16 weeks of observation (median follow-up was 8 weeks), hemoglobin (Hb) significantly increased from (87.70±13.65) g/L to (100.83±16.28) g/L (t= -5.403, P＜0.001). Date from 21 patients who underwent reassessment of hematopoietic parameters showed that ferritin decreased from 197.12 (73.89, 272.93) μg/L to 116.74 (51.78, 242.35) μg/L (Z=         -2.374, P=0.018), while soluble transferrin receptor levels increased from 1.29 (0.89, 2.12) μg/L to 1.78 (1.01, 2.38)μg/L (Z=-2.052, P=0.040). Notably, in patients with malignancies (n=9), Hb increased from (80.89±14.19)g/L to （96.67±18.24）g/L (t=-3.784, P=0.005). Among patients with parathyroid hormone (PTH) ＞300 pg/mL, Hb increased from (82.50±18.20)g/L to (95.50±12.50)g/L (t=-3.227, P=0.006). During treatment and follow-up, 10 patients required intensification of antihypertensive medication, 8 developed hyperkalemia, and 1 experienced arteriovenous fistula thrombotic embolism; no treatment discontinuations due to adverse reactions occurred. No additional clinically significant adverse events were observed.  Conclusion  Enarodustat safely and effectively increases Hb levels in NDD-CKD patients with renal anemia, with consistent efficacy in subgroups with malignancies or secondary hyperparathyroidism. These findings support its potential as a therapeutic option for anemia management in complex clinical settings.

Key words: Enarodustat, Renal anemia, Non-dialysis-dependent chronic kidney disease, Malignant tumor, Secondary hyperparathyroidism