Nicholas, Susanne B. http://orcid.org/0000-0003-3535-9120
Correa-Rotter, Ricardo
Desai, Nihar R.
Guo, Lixin
Navaneethan, Sankar D.
Pantalone, Kevin M.
Wanner, Christoph
Hamacher, Stefanie
Fatoba, Samuel T.
Horvat-Broecker, Andrea
Garreta-Rufas, Antonio
Gay, Alain
Merz, Martin
Wheeler, David C.
Funding for this research was provided by:
Bayer AG, Berlin, Germany
Article History
Received: 12 April 2024
Accepted: 8 August 2024
First Online: 28 September 2024
Declarations
:
: This study is sponsored by Bayer AG. The authors wrote the article with the assistance of a medical writer funded by the sponsor. The sponsor was involved in the study design and the writing of the report. Susanne B. Nicholas is supported by NIH research grants R01MD014712, RF00250-2022-0038, U2CDK129496, P50MD017366, and CDC project number 75D301-21-P-12254; received research support from Bayer AG for the submitted work, as well as research support from Goldfinch Bio, Travere, and Terasaki Institute of Biomedical Innovation; and personal fees and other support from AstraZeneca, Bayer AG, Gilead, Novo Nordisk, and Boehringer Ingelheim/Lilly. Ricardo Correa-Rotter has received consulting and/or speaker and/or advisory board fees and/or research support from AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Chinook, Novo Nordisk and Roche. Nihar Desai works under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures used for public reporting and pay for performance programs. He reports research grants and consulting for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Merck, Novartis, SCPharmaceuticals, and Vifor. Lixin Guo has nothing to disclose. Sankar D. Navaneethan reports receipt of personal fees from AstraZeneca (Data and Safety Monitoring Board), ACI clinical (Clinical Event Committee), Bayer, Boehringer Ingelheim/Lilly, GSK, Intercept, Vifor, and Vertex; and grants from Keryx outside the submitted work. Kevin M. Pantalone discloses speaker bureau fees from AstraZeneca, Corcept Therapeutics, Merck, and Novo Nordisk; consulting fees from AstraZeneca, Bayer, Corcept Therapeutics, Diasome, Eli Lilly, Novo Nordisk, Merck, Sanofi, and Twinhealth; and research support from Bayer, Novo Nordisk, Merck, and Twinhealth. Christoph Wanner reports steering committee and advisory board participation as well as lecturing honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, FMC, Gilead, GSK, MSD, Sanofi, and Vifor. Stefanie Hamacher was an employee of ClinStat GmbH at the time of the study and reports consulting or advisory roles of her former CRO with Bayer AG. Samuel Fatoba is an employee of Bayer U.S. LLC, Pharmaceuticals. Andrea Horvat-Broecker is an employee of Bayer AG, Germany. Antonio Garreta-Rufas is an employee of Bayer AG, Germany. Alain Gay was an employee of Bayer AG, Germany at the time the interim analysis was performed. Martin Merz is an employee of Bayer AG, Germany. David C. Wheeler has received honoraria from Astellas, AstraZeneca (ongoing consultancy agreement), Amgen, Bayer, Boehringer Ingelheim, GSK, Gilead, Janssen, Mundipharma, Merck Sharp and Dohme, Tricida, Vifor, and Zydus.
: Documented approval from appropriate independent ethics committees/institutional review boards was obtained for all participating centers in applicable countries prior to study start. The study is being conducted within an approved drug indication in accordance with guidelines and regulations of the European Medicines Agency, the U.S. Food and Drug Administration [, ], and applicable local laws and regulations.
: Documented approval from appropriate independent ethics committees/institutional review boards was obtained for all participating centers in applicable countries prior to study start. The study is being conducted within an approved drug indication in accordance with guidelines and regulations of the European Medicines Agency, the U.S. Food and Drug Administration, and applicable local laws and regulations. All participants provided written informed consent. This article does not contain any studies with animals performed by any of the authors.
: All participants provided written informed consent.