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8 p, 835.5 KB 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 / Pickkers, Peter (Nijmegen) ; Angus, Derek C (University of Pittsburgh School of Medicine) ; Arend, Jacques (AM-Pharma BV) ; Bellomo, Rinaldo (Austin Hospital) ; van den Berg, Erik (AM-Pharma BV) ; Bernholz, Juliane (AM-Pharma BV) ; Bestle, Morten (Copenhagen) ; Broglio, Kristine (Berry Consultants) ; Carlsen, Jan (AM-Pharma BV) ; Doig, Christopher J ; Ferrer, Ricard (Universitat Autònoma de Barcelona. Departament d'Infermeria) ; Joannidis, Michael (Medical University Innsbruck) ; Francois, Bruno (University of Limoges) ; Doi, Kent (The University of Tokyo Hospital) ; Kellum, John A ; Laterre, Pierre-François (Brussels) ; Liu, Kathleen (University of California San Fransisco) ; Mehta, Ravindra L (University of California) ; Murray, Patrick T (Dublin) ; Ostermann, Marlies (King's College London) ; Pettilä, Ville (Helsinki) ; Richards, Sharon (PHASTAR) ; Young, Paul (Wellington) ; Zarbock, Alexander (Universität Münster) ; Kjølbye, Anne Louise (AM-Pharma BV)
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. [...]
2023 - 10.1136/bmjopen-2022-065613
BMJ open, Vol. 13 (april 2023)  

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