Phenotype-specific therapeutic efficacy of ilofotase alfa in patients with sepsis-associated acute kidney injury.

"Declarations Ethics approval and consent to participateThis trial was conducted in accordance with the protocol and consensus ethical principles of international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. The protocol, the single substantial protocol amendment and other relevant documents were reviewed and approved by the Institutional Research Board (IRB)/Institutional Ethics Committee (IEC) in the relevant centers prior to being used in the trial. Consent for publicationInformed consent was obtained from all patients or the patient’s legal representative. Competing interestsPlease see Additional file 1 for competing interests of the steering committee. The other authors have nothing to disclose. Competing interests Please see Additional file 1 for competing interests of the steering committee. The other authors have nothing to disclose."

"Funding This work was supported by AM-Pharma. The role of the sponsor in the design of the study was to coordinate and facilitate processes, where the scientific input was provided by the members of the protocol committee, steering committee, and specific input by external experts in data management and statistics. The sponsor contracted an external contract research organization to operationally conduct the study at the study sites. The contract research organization was responsible for setting up the technical systems, data collection, quality control, pharmacovigilance, statistics, and further overall management of the study, under coordination and supervision of the sponsor. The statistical analysis plan was prepared by the contract research organization with input by principal investigator, sponsor, and external experts in statistics. The analyses were performed by external contract research organizations. Data were interpreted by the members of the steering committee, and, in a later phase, all coauthors and external experts, coordinated by the sponsor, could provide input. The principal investigator was responsible for preparation of the manuscript. All coauthors reviewed, made adjustments, and approved the manuscript. The decision to submit the manuscript was made by the principal investigator and other coauthors."