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Authors
Goulooze, Sebastiaan Camiel https://orcid.org/0000-0003-3369-6107
Heerspink, Hiddo J. L. https://orcid.org/0000-0002-3126-3730
van Noort, Martijn https://orcid.org/0000-0003-1302-678X
Snelder, Nelleke
Brinker, Meike https://orcid.org/0000-0002-1560-9535
Lippert, Joerg https://orcid.org/0000-0002-0683-2874
Eissing, Thomas https://orcid.org/0000-0003-4378-3423
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Funding
Funding for this research was provided by:
Bayer
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Article History
Accepted: 24 March 2022
First Online: 5 May 2022
Declarations
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: LAP&P conducted the analysis as contract research for Bayer. However, LAP&P (SCG, MvN, NS) and HJLH were not paid to contribute to manuscript preparation.
: SCG, MvN and NS are employed by LAP&P, a CRO working for Bayer. HJLH is co-chairing the executive committee of the ongoing finerenone FIND-CKD trial and advising Bayer including payments. He also had and has various roles in several SGLT2i trials. MB, JL and TE are Bayer employees and potential shareholders of Bayer AG.
: The study protocol was approved by international review boards, independent ethics committees, and competent authorities according to national and international regulations. FIDELIO-DKD was conducted in accordance with the ICH Harmonized Tripartite Guideline for Good Clinical Practice.
: All study participants provided written informed consent before entering the study.
: All study participants provided written informed consent before entering the study.
: Data will be made available in an electronic repository in the future, at a date to be specified by Bayer.
: NONMEM analyses codes are provided as Electronic Supplementary Material.
: SCG: wrote the manuscript, designed the research, performed the population PK/PD analysis and analysed the data; HJLH: wrote the manuscript and designed the research; MvN: performed the population PK/PD analysis and analysed the data; NS: designed the research, supported the population PK/PD analysis and analysed the data; MB: designed the research; JL: designed the research and wrote the manuscript; TE: wrote the manuscript and designed and steered analysis and research.
