Study design
This study was a multicenter, open-label, single-arm, long-term phosphate binder switching, phase 3 study conducted at 30 sites in Japan from March 2021 to June 2022. The institutional review board at each participating site (Sapporo Medical Association's Institutional Review Board, Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board, Yokohama Minoru Clinic Institutional Review Board, Adachi Kyosai Hospital Institutional Review Board, and Jinbo Orthopedic Surgery Institutional Review Board) approved the study protocol and related documents. The list of participating centers is shown in Supplementary Text S1. This study adhered to Good Clinical Practice guidelines, the Declaration of Helsinki, and local laws and regulations. All patients provided written informed consent to participate. The study was registered on 25 February 2021 at ClinicalTrials.gov under the identifier NCT04771780. The study period comprised a 1-week screening period followed by a 52-week treatment period (Fig. (