Roxadustat promotes allograft recovery after kidney transplantation: A prospective, multicenter, randomized controlled trial

Background: Kidney transplantation is the most effective treatment for end-stage kidney disease. However, delayed graft function (DGF) remains a common complication. Roxadustat effectively treats renal anemia and ameliorates acute kidney injury. However, its efficacy in kidney transplant recipients is unclear. Methods: This prospective, multicenter, randomized controlled trial recruited eligible patients undergoing kidney transplantation in two centers between January 2020 and June 2022. The patients were randomly and equally divided into two groups. One group received oral roxadustat (Roxadustat group), while the other group received subcutaneously injected epoetin alfa (Erythropoietin group). The primary endpoint was the DGF rate. Secondary endpoints were hemoglobin levels, graft function, one-year graft and patient survival, and adverse events. Results: The study cohort comprised 112 kidney transplant recipients, with 56 in each group. The DGF rate was lower in the Roxadustat group than in the Erythropoietin group (17.9 % vs. 39.3 %, P = 0.012). The Roxadustat group exhibited significantly higher hemoglobin levels (94.88 ± 15.80 vs. 86.67 ± 11.37 g/L, P = 0.002) and lower Serum creatinine levels (191.06 ± 161.10 vs. 276.09 ± 233.76 μmol/L, P = 0.027) than the Erythropoietin group at 14 days after transplantation. One-year graft (92.9 % vs. 89.3 %, log-rank P = 0.504) and patient (96.4 % vs. 92.9 %, log-rank P = 0.399) survival did not differ between the groups. There were no significant differences in adverse events between the groups. Conclusions: Roxadustat treatment may improve renal anemia, decrease the rate of DGF, and enhance renal graft function in kidney transplant recipients.