Study protocol of a randomised, double-blind, placebo-controlled, two-arm parallel-group, multi-centre phase 3 pivotal trial to investigate the efficacy and safety of recombinant human alkaline phosphatase for treatment of patients with sepsis-associated acute kidney injury

INTRODUCTION: Sepsis, the leading cause of acute kidney injury (AKI), is associated with a high morbidity and mortality. Alkaline phosphatase (ALP) is an endogenous detoxifying enzyme. A recombinant human ALP compound, ilofotase alfa, showed no safety or tolerability concerns in a phase 2 trial. Ren...

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Detalles Bibliográficos
Autores principales: Pickkers, Peter, Angus, Derek C, Arend, Jacques, Bellomo, Rinaldo, van den Berg, Erik, Bernholz, Juliane, Bestle, Morten, Broglio, Kristine, Carlsen, Jan, Doig, Christopher J, Ferrer, Ricard, Joannidis, Michael, Francois, Bruno, Doi, Kent, Kellum, John A, Laterre, Pierre-François, Liu, Kathleen, Mehta, Ravindra L, Murray, Patrick T, Ostermann, Marlies, Pettilä, Ville, Richards, Sharon, Young, Paul, Zarbock, Alexander, Kjølbye, Anne Louise
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Renal Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10083765/
https://www.ncbi.nlm.nih.gov/pubmed/37012016
http://dx.doi.org/10.1136/bmjopen-2022-065613

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