British journal of clinical pharmacology · 2026
Efficacy of roxadustat for anaemia in kidney transplant recipients and its drug-drug interaction with tacrolimus: A retrospective cohort study.
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Qin Haoran, Qian Qing, Xu Jiahao, Xu Yi, Wang Liying, Hu Nan
Аннотация
INTRODUCTION: Post-transplant anaemia is common in kidney transplant recipients (KTRs). Roxadustat is a novel renal anaemia therapy, but its efficacy, safety and interaction with tacrolimus (TAC) in KTRs require further investigation.
METHODS: We conducted a retrospective single-centre cohort study of 145 KTRs with post-transplant anaemia (PTA) (March 2021 to March 2025), stratified by treatment into recombinant human erythropoietin (rhEPO, n = 73) and roxadustat (ROX, n = 72) groups. Endpoints included haemoglobin (Hb) changes, treatment response rates, liver and kidney function markers and TAC pharmacokinetics (trough concentration [C0], dose [D] and C0/D ratio) at 1, 3 and 6 months.
RESULTS: For both groups, at all follow-up points, Hb levels increased significantly from baseline (all P < .05). At 6 months, compared to the rhEPO group, the ROX group showed a significantly higher treatment response rate (∆Hb > 10 g/L: 94.44% vs. 78.08%, P = 0.004) and greater Hb > 120 g/L achievement (80.56% vs. 65.75%, P = .044). No liver/kidney adverse effects were observed in either group. TAC exposure was unchanged in the rhEPO group, while in the ROX group, the C0 increased significantly at 1 and 3 months (P < .05), and C0/D was prominently higher than baseline at 1, 3 and 6 months (P < .01).
CONCLUSION: Roxadustat is an effective oral treatment for PTA, demonstrating superior efficacy to rhEPO at 6 months. However, it is associated with a significant drug-drug interaction that may increase TAC exposure. These findings warrant further prospective studies to validate this drug-drug interaction.
METHODS: We conducted a retrospective single-centre cohort study of 145 KTRs with post-transplant anaemia (PTA) (March 2021 to March 2025), stratified by treatment into recombinant human erythropoietin (rhEPO, n = 73) and roxadustat (ROX, n = 72) groups. Endpoints included haemoglobin (Hb) changes, treatment response rates, liver and kidney function markers and TAC pharmacokinetics (trough concentration [C0], dose [D] and C0/D ratio) at 1, 3 and 6 months.
RESULTS: For both groups, at all follow-up points, Hb levels increased significantly from baseline (all P < .05). At 6 months, compared to the rhEPO group, the ROX group showed a significantly higher treatment response rate (∆Hb > 10 g/L: 94.44% vs. 78.08%, P = 0.004) and greater Hb > 120 g/L achievement (80.56% vs. 65.75%, P = .044). No liver/kidney adverse effects were observed in either group. TAC exposure was unchanged in the rhEPO group, while in the ROX group, the C0 increased significantly at 1 and 3 months (P < .05), and C0/D was prominently higher than baseline at 1, 3 and 6 months (P < .01).
CONCLUSION: Roxadustat is an effective oral treatment for PTA, demonstrating superior efficacy to rhEPO at 6 months. However, it is associated with a significant drug-drug interaction that may increase TAC exposure. These findings warrant further prospective studies to validate this drug-drug interaction.