Bhandari, Sunil http://orcid.org/0000-0002-0996-9622
Parfrey, Patrick
White, Claire
Anker, Stefan D.
Farrington, Kenneth
Ford, Ian
Kalra, Philip A.
McMurray, John J. V.
Robertson, Michele
Tomson, Charles R. V.
Wheeler, David C.
Macdougall, Iain C.
,
Funding for this research was provided by:
KRUK
Article History
Received: 12 August 2022
Accepted: 1 January 2023
First Online: 30 March 2023
Declarations
:
: SB has received honorarium for lectures, attended expert opinion committees and received educational funds to attend international Nephrology meetings from Pharmacosmos A/S and Vifor Pharma, Astellas, Bayer, Pfizer and GSK; PP has no conflicts of interest; CW has no conflicts of interest; SDA has received grants from Vifor Pharma and Abbott Vascular, and fees for consultancy from Vifor Pharma, Bayer, Boehringer Ingelheim, Novartis, and Servier; KF has no conflicts of interest; IF has received research grants from Vifor Pharma and Pharmacosmos; PAK has received speaker fees, honoraria, and consultancy fees from Pharmacosmos, Vifor Pharma, and Takeda. D.C.W. has received honoraria and consultancy fees from Amgen, Akebia, AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, Napp, and Vifor Fresenius Medical Care; JJVM reports receiving fees (all fees from Bayer, fees for serving on a steering committee, fees for serving on an endpoint committee, and travel support from Cardiorentis, fees for serving on a steering committee and travel support from Amgen, fees for serving on a steering committee and travel support from Oxford. University–Bayer, fees for serving as principal investigator of a trial and travel support from Theracos, fees for serving on a steering committee and travel support from AbbVie, fees for serving on a steering committee from DalCor Pharmaceuticals, fees for serving on a data and safety monitoring committee from Pfizer, fees for serving on a data and safety monitoring committee from Merck, fees for serving on an executive committee, fees for serving as co-principal investigator of a trial, fees for serving on a steering committee, fees for serving on an executive committee, travel support, and advisory board fees from Novartis, fees for serving as co-principal investigator for a trial, fees for serving on a steering committee, and travel support from GlaxoSmithKline, fees for serving on a steering committee from Bristol-Myers Squibb, and fees for serving on a steering committee, fees for serving on an endpoint adjudication committee, and travel support from Vifor Pharma–Fresenius; MR has no conflicts of interest; CRVT has no conflicts of interest; DCW has received honoraria and consultancy fees from Amgen, Akebia, AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, Napp, and Vifor Fresenius Medical Care; ICM has received speaker fees, honoraria, and consultancy fees from several ESA and IV iron manufacturers, including Akebia, AMAG, Astellas, Bayer, FibroGen, GlaxoSmithKline, Pharmacosmos, and Vifor Pharma.
: The trial was conducted in compliance with the principles of the Declaration of Helsinki (1996), the principles of good clinical practice (GCP), and in accordance with all applicable regulatory requirements including but not limited to the Research Governance Framework and the Medicines for Human Use (Clinical Trial) Regulations 2004, as amended in 2006 and any subsequent amendments. The trial and all elements of the protocol and revised protocols were approved by the South East Coast - Brighton and Sussex Research Ethics Committee (REC number 13/LO/1115), and to the Medicines and Healthcare products Regulatory Agency (MHRA) for Clinical Trial Authorisation.
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