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Roxadustat-Associated Recurrent Infections in a CKD Patient: A Case Report 

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Abstract Background Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved for the treatment of anemia in patients with chronic kidney disease (CKD). Although randomized clinical trials have reported infections as adverse events, real-world data on infection risk remain limited. Case presentation: We report the case of an 81-year-old female patient with CKD who developed recurrent urinary tract infections and pneumonia following roxadustat therapy. The patient experienced multiple hospitalizations and had laboratory findings consistent with infection during treatment. Despite extensive evaluations, no microbial growth was detected, and sterile pyuria persisted. A Naranjo score of 6 indicated a probable adverse drug reaction. After discontinuation of roxadustat and completion of antibiotic therapy, both clinical symptoms and laboratory markers improved. Conclusion This case highlights the importance of increased clinical awareness regarding the potential immunomodulatory effects of roxadustat, particularly in elderly or immunocompromised CKD patients. Further post-marketing surveillance and real-world studies are needed to better assess its safety profile.
Title: Roxadustat-Associated Recurrent Infections in a CKD Patient: A Case Report 
Description:
Abstract Background Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved for the treatment of anemia in patients with chronic kidney disease (CKD).
Although randomized clinical trials have reported infections as adverse events, real-world data on infection risk remain limited.
Case presentation: We report the case of an 81-year-old female patient with CKD who developed recurrent urinary tract infections and pneumonia following roxadustat therapy.
The patient experienced multiple hospitalizations and had laboratory findings consistent with infection during treatment.
Despite extensive evaluations, no microbial growth was detected, and sterile pyuria persisted.
A Naranjo score of 6 indicated a probable adverse drug reaction.
After discontinuation of roxadustat and completion of antibiotic therapy, both clinical symptoms and laboratory markers improved.
Conclusion This case highlights the importance of increased clinical awareness regarding the potential immunomodulatory effects of roxadustat, particularly in elderly or immunocompromised CKD patients.
Further post-marketing surveillance and real-world studies are needed to better assess its safety profile.

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