Efficacy of roxadustat for anaemia in kidney transplant recipients and its drug–drug interaction with tacrolimus: A retrospective cohort study

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 [C 0 ], dose [D] and C 0 /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 C 0 increased significantly at 1 and 3 months ( P < .05), and C 0 /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.

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Journal
British Journal of Clinical Pharmacology
Published
2026-07-30
DOI
https://doi.org/10.1002/bcp.70713
Primary Topic
Erythropoietin and Anemia Treatment
Type
article
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0.00

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article

Efficacy of roxadustat for anaemia in kidney transplant recipients and its drug–drug interaction with tacrolimus: A retrospective cohort study

Nan Hu, Qing Qian, Haoran Qin, Yi Xu et al.
British Journal of Clinical Pharmacology
Erythropoietin and Anemia Treatment
article

Efficacy of roxadustat for anaemia in kidney transplant recipients and its drug–drug interaction with tacrolimus: A retrospective cohort study

Nan Hu, Qing Qian, Haoran Qin, Yi Xu, Jiahao Xu, Liying Wang
article en

Abstract

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 [C 0 ], dose [D] and C 0 /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 C 0 increased significantly at 1 and 3 months ( P < .05), and C 0 /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.

British Journal of Clinical Pharmacology
Soochow University (CN), The First People's Hospital of Changzhou (CN), Changzhou Third People's Hospital (CN)
Changzhou Science and Technology Bureau
Good health and well-being
Openalex Percentile: Top 9%
Erythropoietin and Anemia Treatment
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