Document is current

Article History

Received: 5 November 2024

Accepted: 25 July 2025

First Online: 11 August 2025

Declarations

:

: The study was conducted in accordance with the protocol, ethical principles of the Declaration of Helsinki, Good Clinical Practice, and International Conference on Harmonisation guidelines, as well as all other applicable regulations. Prior to study implementation, investigators obtained approval from a central institutional review board (IRB; Advarra IRB, Columbia, MD) except for one site that required a local IRB (Committee on the Protection of Human Subjects, Providence, RI). Reporting of data for this study adheres to CONSORT guidelines.

: The purpose and nature of the study, as well as the possibility of adverse effects, were explained to study participants in understandable plain language terms, and written informed consent was obtained from all participants.

: Not applicable.

: P.N.G., D.W., S.K.B., and K.D. are employees of Akebia Therapeutics, Inc., and A.C. is a former employee of Akebia Therapeutics, Inc.