Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL).

"Declarations Conflicts of interestPP has received travel reimbursements and consulting fees from AM-Pharma in relation to his role as PI for REVIVAL, and consulting fees from Adrenomed, EBI Paion, Sphingotec, and 4Teen4 outside the submitted work. DCA has received consulting fees from AM-Pharma. KB, AM-Pharma BV, The Netherlands. RB has received consulting fees and research support from AM-Pharma, Baxter, Paion, Viatris, Jafron Biomedical, and CSL Behring. EvdB, AM-Pharma BV, The Netherlands. JB, AM-Pharma BV, The Netherlands. MHB has received consulting fees from AM-Pharma in relation to his role for REVIVAL and has conducted contract research for Inotrem outside of the submitted work. KD has received consulting fees from AM-Pharma. CJD reports no conflicts of interest. RF has received consulting fees from AM-Pharma. BF has received consulting fees from AM-Pharma as a member of the REVIVAL steering committee, and consulting fees from Inotrem, Aridis, and Enlivex outside the submitted work. HG reports funding from various companies in the form of research grants to (and administered by) Aarhus University or Aarhus University Hospital. HG has received support for attending meetings by Baxter A/S. UGP reports no conflicts of interest. EH has received a travel grant from AM-Pharma. SI reports no conflicts of interest. Michael Joannidis has received honoraria or research support from Baxter Healthcare Corp, AM-Pharma, CLS Behring, Fresenius, Takeda, Sanofi and Novartis. JAK discloses fees paid by AM-Pharma in relation to his role as national PI for REVIVAL and is currently a full-time employee of Spectral Medical. KL has been a member of the REVIVAL Steering Committee for AM Pharma. She has been a consultant/member of the DSMB for Seastar, Novartis, BOA Medical, Baxter, and Biomerieux, and she holds stock in Amgen. MM has received lecture fees from Baxter and Fresenius Medical Care. RM reports honoraria for consulting from Baxter, Biomerieux, Mallinckrodt, GE Healthcare, Sanofi, Abiomed, NovaBiomed, Renasym, and advisory board reimbursements from AM Pharma, Renibus, Alexion, Novartis, and Guard. SM reports no conflicts of interest. PTM has received consulting fees from AM-Pharma (for Clinical Trial Steering Committee activities), Novartis, Renibus Therapeutics, and Alexion. AN reports an unrestricted grant from Baxter to support the renal substudy of the TAME trial. MO has received speaker honoraria from Fresenius Medical, Baxter and Biomerieux; her institution received research funding from Baxter, Fresenius Medical, Biomerieux, and LaJolla Pharma. CS reports no conflicts of interest. PV reports no conflicts of interest. MW, AM-Pharma BV, The Netherlands. PJY has received consulting fees from AM Pharma and from Baxter Healthcare Pty. AZ has received consulting fees from Astute-Biomerieux, Baxter, Bayer, Novartis, Guard Therapeutics, AM Pharma, Paion, Renibus, Fresenius, research funding from Astute-Biomerieux, Fresenius, Baxter, and speakers fees from Astute-Biomerieux, Fresenius, Baxter. Conflicts of interest PP has received travel reimbursements and consulting fees from AM-Pharma in relation to his role as PI for REVIVAL, and consulting fees from Adrenomed, EBI Paion, Sphingotec, and 4Teen4 outside the submitted work. DCA has received consulting fees from AM-Pharma. KB, AM-Pharma BV, The Netherlands. RB has received consulting fees and research support from AM-Pharma, Baxter, Paion, Viatris, Jafron Biomedical, and CSL Behring. EvdB, AM-Pharma BV, The Netherlands. JB, AM-Pharma BV, The Netherlands. MHB has received consulting fees from AM-Pharma in relation to his role for REVIVAL and has conducted contract research for Inotrem outside of the submitted work. KD has received consulting fees from AM-Pharma. CJD reports no conflicts of interest. RF has received consulting fees from AM-Pharma. BF has received consulting fees from AM-Pharma as a member of the REVIVAL steering committee, and consulting fees from Inotrem, Aridis, and Enlivex outside the submitted work. HG reports funding from various companies in the form of research grants to (and administered by) Aarhus University or Aarhus University Hospital. HG has received support for attending meetings by Baxter A/S. UGP reports no conflicts of interest. EH has received a travel grant from AM-Pharma. SI reports no conflicts of interest. Michael Joannidis has received honoraria or research support from Baxter Healthcare Corp, AM-Pharma, CLS Behring, Fresenius, Takeda, Sanofi and Novartis. JAK discloses fees paid by AM-Pharma in relation to his role as national PI for REVIVAL and is currently a full-time employee of Spectral Medical. KL has been a member of the REVIVAL Steering Committee for AM Pharma. She has been a consultant/member of the DSMB for Seastar, Novartis, BOA Medical, Baxter, and Biomerieux, and she holds stock in Amgen. MM has received lecture fees from Baxter and Fresenius Medical Care. RM reports honoraria for consulting from Baxter, Biomerieux, Mallinckrodt, GE Healthcare, Sanofi, Abiomed, NovaBiomed, Renasym, and advisory board reimbursements from AM Pharma, Renibus, Alexion, Novartis, and Guard. SM reports no conflicts of interest. PTM has received consulting fees from AM-Pharma (for Clinical Trial Steering Committee activities), Novartis, Renibus Therapeutics, and Alexion. AN reports an unrestricted grant from Baxter to support the renal substudy of the TAME trial. MO has received speaker honoraria from Fresenius Medical, Baxter and Biomerieux; her institution received research funding from Baxter, Fresenius Medical, Biomerieux, and LaJolla Pharma. CS reports no conflicts of interest. PV reports no conflicts of interest. MW, AM-Pharma BV, The Netherlands. PJY has received consulting fees from AM Pharma and from Baxter Healthcare Pty. AZ has received consulting fees from Astute-Biomerieux, Baxter, Bayer, Novartis, Guard Therapeutics, AM Pharma, Paion, Renibus, Fresenius, research funding from Astute-Biomerieux, Fresenius, Baxter, and speakers fees from Astute-Biomerieux, Fresenius, Baxter."

"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."