Document is current

Article History

Accepted: 18 July 2024

First Online: 5 August 2024

Declarations

:

: GL, FHF, MLB, and GS have no conflict of interest. MW has been a recent consultant to Amgen and Freeline. MT is an employee of Diaverum. JH serves on the Board of Directors of NorrDia AB and provides consultancy services to Triomed AB. AD has received fees from Fresenius Medical Company and Nipro Corporation for speaking at scientific meetings and attending advisory groups. KC is an employee of Fresenius Medical Care Deutschland GmbH. BC was a former employee and acting as scientific consultant for Fresenius Medical Care Deutschland GmbH. PJB has been a recent consultant to Medtronic and has received payment from Fresenius. CB is an employee of B. Braun Avitum AG (Chief Medical Officer) and member of the supervisory board of the B. Braun Melsungen AG, Germany. KIF is a former employee of Roche and is a current employee of Boehringer Ingelheim. MR is a senior advisor at the PROMIS National Center Germany.

: The trial, which was funded by the European Commission Research and Innovation, Horizon 2020, was conducted in accordance with the principles of the Declaration of Helsinki and the respective laws and regulations of the participating countries. Written informed consent was obtained according to these principles, along with the provisions of the General Data Protection Regulation Directive and local regulations. The trial was initiated by the investigators and was designed and overseen by a steering committee consisting of academic investigators and employees of dialysis providers independent of financial contributors. The following IRBs approved the study protocol in each participating country:France: Comité de protection des personnes Ile de France II (19.07.22.44859 RIPH 2 HPS).Germany: Ethikkommission an der Universitätsmedizin Greifswald Institut für Pharmakologie (BB058/18).Hungary: Országos Gyógyszerészeti és Élelmezés-egészégügyi Intézet (OGYÉI/6823).Netherlands: Medisch-Ethische Toetsingscommissie NedMec (18–260/D).Poland: KomisJa Bioetyczna przy Slnskiej lzbie Lekarskiej w Katowicach (7/2019).Portugal: Comissão de Ética para a Investigação Clínica (2019_EI_05).Romania: Comisia Naţională de Bioetică a Medicamentului şi a Dispozitivelor Medicale (10SNI/18.07.2019).Spain: CEIm Provincial de Málaga Hospital Regional Universitario de Málaga (1551-M3-21).United Kingdom: East Midlands—Leicester Central Research Ethics Committee (18/EM/0213).