DOI: 10.12890/2026_007262

Roxadustat-associated cholestatic jaundice in haemodialysis patients with positive rechallenge

Authors

  • Xiaosu Ke Department of Nephrology, Guangdong Zhongnengjian Electric Power Hospital, Guangzhou, China; Department of Nephrology, Guangdong Sanjiu Brain Hospital, Guangzhou, China 0000-0002-4222-1712
  • Churong Liu Department of Rehabilitation Medicine, Guangdong Zhongnengjian Electric Power Hospital, Guangzhou, China; Department of Rehabilitation Medicine, Guangdong Sanjiu Brain Hospital, Guangzhou, China 0009-0005-1339-7961

kexiaosu@163.com

Keywords

Roxadustat, cholestatic jaundice, HIF-PHI, haemodialysis

Abstract

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is widely used for anaemia in chronic kidney disease. While pivotal trials reported low risks of transaminase elevations, detailed clinical case reports substantiating a causal link with cholestatic jaundice remain scarce. We report a series of four haemodialysis patients who developed cholestatic jaundice after roxadustat initiation, characterized by predominant elevations of direct bilirubin and bile acids with persistently normal transaminases. Notably, two patients had positive rechallenges. Common causes of cholestasis were excluded, and biochemical recovery occurred after drug discontinuation. This case report suggests a causal association between roxadustat and cholestatic jaundice in haemodialysis patients and highlights the value of monitoring cholestatic parameters during therapy.

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References

  1. Chen N, Hao C, Liu BC, Lin H, Wang C, Xing C, et al. Roxadustat treatment for anemia in patients undergoing long-term dialysis. N Engl J Med 2019;381:1011-1022. doi: 10.1056/NEJMoa1901713
  2. Chen N, Hao C, Peng X, Lin H, Yin A, Hao L, et al. Roxadustat for anemia in patients with kidney disease not receiving dialysis. N Engl J Med 2019;381:1001-1010. doi: 10.1056/NEJMoa1813599
  3. Chen N, Qian J, Chen J, Yu X, Mei C, Hao C, et al. Phase 2 studies of oral hypoxia-inducible factor prolyl hydroxylase inhibitor fg-4592 for treatment of anemia in china. Nephrol Dial Transplant 2017;32:1373-1386. doi: 10.1093/ndt/gfx011
  4. Huang JH, Li N. Signal mining and analysis of adverse events of roxadustat based on the jader database. Drugs & Clinic 2024;39:2684-2689. doi: 10.7501/j.issn.1674-5515.2024.10.040
  5. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-245. doi: 10.1038/clpt.1981.154
  6. Teschke R, Danan G. Idiosyncratic dili and rucam under one hat: the global view. Livers 2023;3:397-434. doi: 10.3390/livers3030030
  7. Chen J, Zhang S. The role of inflammation in cholestatic liver injury. J Inflamm Res 2023;16:4527-4540. doi: 10.2147/JIR.S430730
  8. Zhou HS, Huang HW, Xu H, Xiao G, Yuan QJ. Is roxadustat responsible for the jaundice of a dialysis patient with beta-thalassemia? A case report. In: Liu BC, editor. Treatment of Refractory Renal Anemia: Case Collection, Singapore: Springer; 2025, p. 163-6.
  9. Solanki S, Shah YM. Hypoxia-induced signaling in gut and liver pathobiology. Annu Rev Pathol 2024;19:291-317. doi: 10.1146/annurev-pathmechdis-051122-094743
  10. Fouassier L, Beaussier M, Schiffer E, Rey C, Barbu V, Mergey M, et al. Hypoxia-induced changes in the expression of rat hepatobiliary transporter genes. Am J Physiol Gastrointest Liver Physiol 2007;293:G25-G35. doi: 10.1152/ajpgi.00175.2006
  11. Kraus A, Peters D, Klanke B, Weidemann A, Willam C, Schley G, et al. Hif-1alpha promotes cyst progression in a mouse model of autosomal dominant polycystic kidney disease. Kidney Int 2018;94:887-899. doi: 10.1016/j.kint.2018.06.008

Published

2026-08-10

How to Cite

1.
Ke X, Liu C. Roxadustat-associated cholestatic jaundice in haemodialysis patients with positive rechallenge. EJCRIM [Internet]. 2026 Aug. 10 [cited 2026 Nov. 3];13(8). Available from: https://ejcrim.com/index.php/ejcrim/article/view/7262