Roxadustat in Kidney Transplant Recipients with ESA-Hyporesponsive Anemia: A Prospective Single-Center Cohort Study

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates erythropoiesis. This prospective single-center, non-randomized, single-arm cohort study enrolled renal transplant recipients with refractory anemia, defined as hemoglobin (Hb) ≤10 g/dL despite receiving the maximum doses of erythropoiesis-stimulating agents for 12 weeks. The studied parameters were Hb, ferritin, iron saturation index, glomerular filtration rate (eGFR), and C-reactive protein (CRP). Follow-up assessments were conducted at 4, 8, and 12 weeks after starting Roxadustat. The primary endpoint was the proportion of patients achieving Hb > 11 g/dL at 12 weeks. Secondary endpoints included changes from baseline in studied parameters and adverse effects. Twenty recipients (11 male, 9 female) with a median age of 69.0 years and a median time post-transplant of 62.5 months were included. Median baseline eGFR was 16.5 mL/min/1.73 m². At 12 weeks, 19 of 20 (95%) achieved Hb > 11 g/dL. Median Hb increased significantly from 9.1 g/dL to 11.5 g/dL, with a median individual change of +2.7 g/dL (IQR 1.7-3.4; p < 0.001). The only non-responder increased Hb from 9.5 to 10.2 g/dL. Ferritin decreased significantly over 12 weeks, whereas no statistically significant changes were observed in transferrin saturation, CRP, or eGFR. No serious adverse events were observed. In this prospective cohort, roxadustat was associated with short-term hemoglobin improvement and high Hb target attainment; however, these findings should be interpreted cautiously given the single-arm design and limited sample size.