Kanda, Eiichiro
Rastogi, Anjay
Murohara, Toyoaki
Lesén, Eva
Agiro, Abiy
Arnold, Matthew
Chen, Gengshi
Yajima, Toshitaka
Järbrink, Krister
Pollack, Charles V. Jr
Article History
Received: 28 September 2022
Accepted: 28 December 2022
First Online: 19 January 2023
Declarations
:
: This observational study was performed in accordance with ethical principles consistent with the Declaration of Helsinki, International Confederation on Harmonization Good Clinical Practice Guidelines, and Good Publication Practice recommendations, and applicable legislation on Non-Interventional Studies and/or Observational Studies. As this study solely involved secondary analysis of de-identified data, Institutional Review Board approvals or individual patient consent were not needed. According to the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects, ethical approval and informed consent do not apply to the use of de-identified secondary data. In the United States, local data source requirements were followed; access to the de-identified data was approved via Optum’s internal HIPAA Disclosure Analysis review process prior to data delivery, and Institutional Review Board approval was not required.
: Not applicable.
: E.K. declares no competing interests.A.R. has received institutional support relating to research grants from Alnylam Pharmaceuticals, AstraZeneca, Bayer, Gilead, GSK, Idorsia Pharmaceuticals Ltd., the National Institutes of Health, Novo Nordisk, Kadmon Corporation (LLC), Omeros Inc., Otsuka Pharmaceuticals, Palladio Biosciences, Pfizer, Protalix Biotherapeutics Ltd., Reata Pharmaceuticals, Regulus Therapeutics, Summit Therapeutics, and Sanofi; consulting fees or support for participation in advisory boards from Akebia, Amgen, Ardelyx, AstraZeneca, Aurinia, Baxter, Chiesi Global Inc., Chinook Therapeutics, Fresenius Medical Care, GSK, Otsuka, Relypsa, Sanofi, Tricida, and Vifor Pharma Inc.; speaker fees from Amgen, AstraZeneca, Aurinia, Bayer, Baxter, Fresenius Medical Care, Genzyme/Sanofi, Janssen, National Kidney Foundation, Vifor Pharma Inc., and Natera; provision of expert testimony from Quinn Emanuel Urquhart & Sullivan (LLP), and Bowman and Brooke Attorneys at Law; and, for attending meetings and/or travel from all of the above.T.M. has received honoraria for educational materials from AstraZeneca, Lilly, and Boehringer Ingelheim Japan.M.A. is an employee of AstraZeneca. E.L., A.A., G.C., T.Y., and K.J. are employees of, and hold stock/stock options in, AstraZeneca.C.V.P. has received consultancy fees from AstraZeneca.