The Efficacy and Safety of Roxadustat for the Treatment of Posttransplantation Anemia: A Randomized Study

作者：Weiwei Kong, Xiaoying Wu, Zhuowei Shen, Meifang Wang, Xinyu Liu, Xiaoli Lin, Yingyin Qiu, Hong Jiang, Jianghua Chen, Yan Lou, Hongfeng Huang · 发表于：Kidney International Reports · 年份：2024 · DOI：10.1016/j.ekir.2024.04.021 · 被引用次数：19 · 研究领域：Erythropoietin and Anemia Treatment、Cancer, Hypoxia, and Metabolism、Blood transfusion and management

Introduction: Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, can stimulate erythropoiesis. Our objective was to evaluate the efficacy and safety of roxadustat for the treatment of posttransplantation anemia (PTA). Methods: A total of 150 adult renal transplant recipients who underwent PTA were randomized to either the experimental group or the control group. During the 12-week randomized phase, the experimental group was randomized to oral iron and roxadustat treatment, and the control group was randomized to oral iron treatment only. The randomized phase was followed by a 12-week extended treatment period in which all participants were prescribed roxadustat treatment according to hemoglobin (Hb) levels. All the participants were followed-up with every 4 weeks. The primary end points were the change in Hb levels and response rate throughout the randomized period. Results: A total of 128 participants completed the randomized treatment period (90 in the experimental group and 38 in the control group). The mean Hb concentration at week 12 was 12.20 g/dl in the experimental group and 11.19 g/dl in the control group. A significantly higher proportion of participants who achieved Hb responses were in the experimental group than in the control group. Differences in serum iron, total iron-binding capacity (TIBC) and transferrin from baseline to week 8 to 12 were significant between the 2 groups. The adverse event profiles were comparable between t...