Study concept and design: Bakris, Pitt, Weir, Freeman, Stasiv, Berman, Bushinsky.
Acquisition, analysis, or interpretation of data: Pitt, Weir, Freeman, Mayo, Garza, Zawadzki, Berman, Bushinsky.
Drafting of the manuscript: Bakris, Pitt, Freeman, Mayo, Berman.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Mayo, Zawadzki.
Obtained funding: Mayo.
Administrative, technical, or material support: Bakris, Mayo, Stasiv, Berman, Bushinsky.
Study supervision: Bakris, Garza, Berman, Bushinsky.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Bakris reported receiving personal fees from AbbVie, Takeda, Medtronic, Relypsa, Daiichi-Sankyo, Janssen, Novartis, and Bayer and receiving grants from Takeda. Dr Pitt reported receiving personal fees from Relypsa, Pfizer, Bayer, AstraZeneca, Tricida, scPharmaceuticals, DaVinci Therapeutics, Stealth Peptides, Aura Sense, Sarfez, Novartis, Johnson & Johnson, Oxygen Biotherapeutics, and Eli Lilly and holding patent EFS ID: 14916043, application 61762661,/UM-33001/US-1PRO pending. Dr Weir reported receiving personal fees from Relypsa, ZS Pharma Akebia, Janssen, AstraZeneca, Otsuka, Amgen, MSD, AbbVie, Novartis, Boston Scientific, and Sandoz. Dr Freeman reported receiving personal fees from Relypsa and receiving stock option grants for involvement in helping design the overall clinical trial program for patiromer. Dr Zawadzki reported receiving personal fees from Relypsa. Dr Berman reported holding patent WO 2014/058905 pending. Dr Bushinsky reported receiving personal fees from Relypsa. No other authors reported disclosures.
Funding/Support: This study was sponsored and funded by Relypsa.
Role of the Funder/Sponsor: Relypsa and the steering committee designed the study. Relypsa conducted the study, data collection, and management analysis. Relypsa, with the steering committee, was responsible for the interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The funder/sponsor did not have the ability to veto publication of study results.
Additional Contributions: Mark Mortier, PhD (Agility Clinical Inc), and Carol Francisco, PhD (consultant to Relypsa), contributed to the finalization of the statistical analysis plan and the analysis of data and were funded by Relypsa. Robert E. Lamb, PharmD (REL & Associates LLC), developed the first draft of the Methods and Results sections under the direction of the first author and was funded by Relypsa. Julie Ann Obeid, BA (Relypsa), and Cole Brown, MD (AlphaBioCom), provided additional editorial support. Ms Obeid and Dr Brown received no compensation for their contributions.
Correction: This article was corrected online on July 20, 2015, to correct a reported dose in a figure.