Document is current

Article History

Received: 17 December 2024

Accepted: 25 March 2025

First Online: 3 April 2025

Declarations

:

: The study has been approved by Ethics Committees in Italy (Turin Regional Ethics Committee, 0000138, October 3 2024), Sweden (Ethical Review Authority, 2023-02927-01, May 15 2023), and United Kingdom (North West - Greater Manchester South Research Ethics Committee, 23/NW/0138, June 22 2023). The study has been approved by the competent authorities in Italy (Ministry of Health, DGDMF/I.5.i.m.2/2024/2224, August 27 2024), Sweden (Medical Products Agency, 5.1-2023-29063, May 5 2023), and United Kingdom (Medicines and Healthcare products Regulatory Agency, CI/2023/0030/GB, April 17 2023). All subjects will be asked by the principal investigator or a co-investigator at the site to sign an informed consent form prior to entering the study. Consent forms have been modified according to Ethics Committees/competent authorities in the three countries separately.

: The sponsor will maintain appropriate clinical study insurance coverage as required under applicable laws and regulations for the duration of the clinical investigation.

: This publication will not include any sensitive or traceable data.

: MW reports consultancy for Triomed AB, speakers honoraria from Baxter, and editorial links with International Society for Peritoneal Dialysis. CDL and OC report employment with Triomed AB. JH serves on the Board of Directors of NorrDia AB, and provides consultancy services to Triomed AB and myjoju Ltd. OH reports research funding from AstraZeneca, Baxter, and Triomed AB; honoraria from AstraZeneca, Baxter Healthcare, Bayer, Ewimed, Fresenius Medical Care, and Vifor for presentations at company-organized courses; speakers bureau for AstraZeneca; and role on Editorial Boards of Blood Purification, Clinical Nephrology, and Peritoneal Dialysis International.