Fotheringham, James http://orcid.org/0000-0002-8980-2223
Guest, Julian
Latus, Joerg
Lerma, Edgar
Morin, Isabelle
Schaufler, Thilo
Soro, Marco
Ständer, Sonja
Zeig, Steven
Funding for this research was provided by:
Vifor Pharma
Article History
Accepted: 10 December 2023
First Online: 9 January 2024
Declarations
:
: The open-label trial was funded by Cara Therapeutics Inc., Stamford, Connecticut, USA. This manuscript was commissioned and funded by CSL Vifor, St Gallen, Switzerland.
: James Fotheringham reports speaker honoraria from Fresenius Medical Care and Novartis, and conducts research funded by CSL Vifor and Novartis. Julian Guest reports consultancy fees from Vifor Fresenius Medical Care. Joerg Latus reports consultancy fees from CSL Vifor. Edgar Lerma reports speaker/advisory board/steering committee involvements with Akebia, AstraZeneca, Bayer, Glaxo Smith Kline, Otsuka, Travere and CSL Vifor. Isabelle Morin, Thilo Schaufler and Marco Soro report that they are employees and shareholders of CSL Vifor. Sonja Ständer has received consulting and advisory board fees from AbbVie, Almirall, Beiersdorf, Bellus Health, Benevolent, Bionorica, Cara, Clexio, DS Biopharma, Eli Lilly, Galderma, Integrity CE, Kiniksa, Klinge Pharma, Leo Pharma, Pfizer, Sanofi Regeneron, TouchIME, Trevi, Vifor and WebMD; speaker fees from Almirall, BMS, Eli Lilly, Sanofi, Galderma, L’Oréal, Omnicuris, Beiersdorf, Leo Pharma, Novartis, P.G. Unna Academy, Pfizer, UCB and Vifor; and research grants from Almirall, German Research Foundation (DFG), European Academy of Dermatology and Venereology (EADV), Leo Pharma, Novartis, Sanofi and Trevi Therapeutics. Steven Zeig reports consultancy fees from CSL Vifor.
: The data that support the findings of this study are not publicly available due to their containing information that could compromise the privacy of research participants but are available from the corresponding author (James Fotheringham).
: This study was approved by a combination of institutional review boards or independent ethics committees depending on the geographical location of the study centre. The institutional review boards/independent ethics committees reviewed and approved all study documentation to safeguard the rights, safety, and well-being of the patients. The study protocol was reviewed and approved by institutional review boards before the study commenced (Study 3105: WCG IRB, approval number 20190622). The study was carried out in accordance with the principles of the Declaration of Helsinki [CitationRef removed].
: All patients gave written informed consent prior to study enrolment.
: Not applicable as individual patient data are not presented.
: All authors participated in the data analysis and preparation of the manuscript and approved the final manuscript for publication. Research idea: James Fotheringham, Thilo Schaufler, Marco Soro, Steven Zeig; data acquisition: Isabelle Morin, Thilo Schaufler, Marco Soro, James Fotheringham; data analysis and interpretation: James Fotheringham, Julian Guest, Joerg Latus, Edgar Lerma, Isabelle Morin, Thilo Schaufler, Marco Soro, Sonja Ständer, Steven Zeig. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved.