Document is current

Article History

Received: 24 September 2025

Accepted: 24 November 2025

First Online: 9 December 2025

Declarations

:

: The TwoPlus trial and this monitoring protocol have been approved by the Institutional Review Boards (IRBs) of all participating institutions. Written informed consent is obtained from all participants prior to enrollment.

: Not applicable.

: The TwoPlus trial has been registered at ClinicalTrials.gov; NCT05828823; registration date: April 25, 2023. Recruitment for the TwoPlus trial began in January 2024 and was initiated in a staggered fashion across participating sites over the subsequent months. As of September 2025, enrollment and randomization remain ongoing at academic and community dialysis units throughout the United States.

: All data are handled in accordance with institutional and federal regulations. Identifiable information is stored only at the enrolling site. De-identified data are transferred to the Data Coordinating Center for analysis.

: Study results will be disseminated through peer-reviewed publications, conference presentations, and engagement with stakeholders including dialysis providers, professional societies, and patient advocacy groups. Authorship will follow International Committee of Medical Journal Editors (ICMJE) guidelines. A lay summary will be prepared for participants and made publicly available.

: The authors declare no competing interests.