Groenendaal-van de Meent, Dorien http://orcid.org/0000-0001-9315-3257
Kerbusch, Virginie
Kaspera, Rudiger
Barroso-Fernandez, Begona
Galletti, Piergiorgio
Klein, Gernot K.
den Adel, Martin
Article History
First Online: 9 November 2020
Declarations
:
: Roxadustat is being developed by FibroGen, AstraZeneca, and Astellas. This study was funded by Astellas Pharma, Inc.
: V. Kerbusch reported personal fees from Astellas Pharma, Inc. during the conduct of the study and outside the submitted work. B. Barroso-Fernandez, M. den Adel, and R. Kaspera were employees of Astellas Pharma, Inc. during the conduct of the study. P. Galletti was contracted by Astellas Pharma, Inc. during the conduct of the study. D. Groenendaal-van de Meent is an employee of Astellas Pharma, Inc. G. Klein has nothing to disclose.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study protocol (NCT02965040) was reviewed and approved by two Independent Ethics Committees (East of England –Cambridge East Research Ethics Committee and Technische Universität Műnchen, Fakultät Fűr Medizin-Ethikkommission).
: All study participants signed a written informed consent.
: Researchers may request access to anonymized participant level data, trial level data and protocols from Astellas sponsored clinical trials at ExternalRef removed. For the Astellas criteria on data sharing see: ExternalRef removed.
: DGM, MA, and VK contributed to the study conception and design. BBF, PG, GKK, and VK contributed to the acquisition of data. GKK contributed to the analysis and interpretation of the data. DGM, MA, RK, and VK participated in the analysis and interpretation of the data and in the drafting of this article. All authors provided critical revision of the article for important intellectual content.