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Peer-reviewedCC BY 4.0Therapeutic Apheresis and Dialysis

Safety of Daprodustat for the Treatment of Chronic Kidney Disease Anemia: Final Analysis of a Multicenter Postmarketing Surveillance Study in Japan

  • Tadao Akizawa1
  • Kyomi Kanaya2
  • Kiyomi Aizawa2
  • Masanori Onoki3
  • Hirofumi Ozeki4
  • Kazuko Suzuki5
  • Ai Hayashi6
  • Tomohiko Asamura6
6 affiliations
  1. 1Division of Nephrology, Department of Medicine Showa Medical University Tokyo Japan
  2. 2Real‐World Data Analytics, Biostatistics, Asia Development GlaxoSmithKline K.K Tokyo Japan
  3. 3Safety Risk Evaluation, Clinical Safety & Pharmacovigilance GlaxoSmithKline K.K Tokyo Japan
  4. 4Specialty Medical Affairs, Specialty Medical Affairs and Development, Japan Medical Affairs GlaxoSmithKline K.K Tokyo Japan
  5. 5Safety Evaluation & Risk Management, Clinical Safety & Pharmacovigilance GlaxoSmithKline K.K Tokyo Japan
  6. 6Real‐World Evidence & Health Outcome Research, Japan Medical Affairs GlaxoSmithKline K.K Tokyo Japan
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Abstract

Introduction: This final analysis of a multicenter, prospective postmarketing surveillance study evaluated the safety of daprodustat in patients with chronic kidney disease anemia in routine clinical practice in Japan.

Methods: Patients who initiated daprodustat between September 2020 and July 2022 were registered. The observation period was 52 weeks from treatment start or until discontinuation to assess overall safety, with an additional 52‐week follow‐up for cancer‐related events.

Results: Of 1634 patients in the safety analysis set, adverse drug reactions (ADRs) occurred in 5.6% (4.8% not undergoing dialysis; 6.9% undergoing peritoneal dialysis; 6.6% undergoing hemodialysis) and serious ADRs in 2.2%. ADRs related to thromboembolism, hypertension, cardiovascular events, cancer, and retinal hemorrhage were reported in less than 1%, with no progression of autosomal dominant polycystic kidney disease. During follow‐up, no increase in cancer‐related events was observed.

Conclusions: No new safety concerns were identified for daprodustat in the real‐world setting in Japan.

Trial Registration: GSK study: 214119

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Cite

BibTeXRIS
BibTeX
@article{akizawa2026safety,
  title = {{Safety of Daprodustat for the Treatment of Chronic Kidney Disease Anemia: Final Analysis of a Multicenter Postmarketing Surveillance Study in Japan}},
  author = {Tadao Akizawa and Kyomi Kanaya and Kiyomi Aizawa and Masanori Onoki and Hirofumi Ozeki and Kazuko Suzuki and Ai Hayashi and Tomohiko Asamura},
  journal = {Therapeutic Apheresis and Dialysis},
  year = {2026},
  month = jul,
  doi = {10.1002/1744-9987.70182},
  url = {https://doi.org/10.1002/1744-9987.70182},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Safety of Daprodustat for the Treatment of Chronic Kidney Disease Anemia: Final Analysis of a Multicenter Postmarketing Surveillance Study in Japan
AU  - Tadao Akizawa
AU  - Kyomi Kanaya
AU  - Kiyomi Aizawa
AU  - Masanori Onoki
AU  - Hirofumi Ozeki
AU  - Kazuko Suzuki
AU  - Ai Hayashi
AU  - Tomohiko Asamura
PY  - 2026
DA  - 2026/07/06
JO  - Therapeutic Apheresis and Dialysis
DO  - 10.1002/1744-9987.70182
UR  - https://doi.org/10.1002/1744-9987.70182
AB  - Introduction: This final analysis of a multicenter, prospective postmarketing surveillance study evaluated the safety of daprodustat in patients with chronic kidney disease anemia in routine clinical practice in Japan.  Methods: Patients who initiated daprodustat between September 2020 and July 2022 were registered. The observation period was 52 weeks from treatment start or until discontinuation to assess overall safety, with an additional 52‐week follow‐up for cancer‐related events.  Results: Of 1634 patients in the safety analysis set, adverse drug reactions (ADRs) occurred in 5.6% (4.8% not undergoing dialysis; 6.9% undergoing peritoneal dialysis; 6.6% undergoing hemodialysis) and serious ADRs in 2.2%. ADRs related to thromboembolism, hypertension, cardiovascular events, cancer, and retinal hemorrhage were reported in less than 1%, with no progression of autosomal dominant polycystic kidney disease. During follow‐up, no increase in cancer‐related events was observed.  Conclusions: No new safety concerns were identified for daprodustat in the real‐world setting in Japan.  Trial Registration: GSK study: 214119
SN  - 1744-9979
SN  - 1744-9987
ER  -