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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
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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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14 p, 1.9 MB |
Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients : a randomised controlled trial
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Chastre, Jean (Service de Médecine Intensive Réanimation. Institut de Cardiologie. Groupe Hospitalier Pitié-Salpêtrière. Assistance Publique-Hôpitaux de Paris. Sorbonne University) ;
François, Bruno (Réanimation Polyvalente and Inserm CIC 1435 & UMR 1092. CHU) ;
Bourgeois, Marc (AZ Sint-Jan Brugge-Oostende AV) ;
Komnos, Apostolos (General Hospital of Larissa) ;
Ferrer, Ricard (Hospital Universitari Vall d'Hebron) ;
Rahav, Galia (Chaim Sheba Medical Center. Sackler School of Medicine. Tel Aviv University) ;
De Schryver, Nicolas (Clinique Saint-Pierre) ;
Lepape, Alain (Hospices Civils de Lyon Hôpital Lyon Sud) ;
Koksal, Iftihar (Faculty of Medicine. Trabzon and Acibadem University Faculty of Medicine. Karadeniz Technical University) ;
Luyt, Charles-Edouard (Service de Médecine Intensive Réanimation. Institut de Cardiologie. Groupe Hospitalier Pitié-Salpêtrière. Assistance Publique-Hôpitaux de Paris. Sorbonne University) ;
Sánchez-García, Miguel (Hospital Clínico San Carlos (Madrid)) ;
Torres, Antoni (Hospital Clínic i Provincial de Barcelona) ;
Eggimann, Philippe (Department of Locomotor Apparatus. Centre Hospitalier Universitaire Vaudois CHUV) ;
Koulenti, Despoina (2nd Critical Care Department. Attikon University Hospital. National and Kapodistrian. University of Athens) ;
Holland, Thomas L. (Duke Clinical Research Institute) ;
Ali, Omar (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Shoemaker, Kathryn (Respiratory and Immunology. BioPharmaceuticals R&D. AstraZeneca) ;
Ren, Pin (Respiratory and Immunology. BioPharmaceuticals R&D. AstraZeneca) ;
Sauser, Julien (Infection Control Program. Faculty of Medicine. Geneva University Hospitals) ;
Ruzin, Alexey (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Tabor, David E. (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Akhgar, Ahmad (Clinical Pharmacology and Quantitative Pharmacology. Clinical Pharmacology and Safety Sciences. BioPharmaceuticals R&D. AstraZeneca) ;
Wu, Yuling (Clinical Pharmacology and Quantitative Pharmacology. Clinical Pharmacology and Safety Sciences. BioPharmaceuticals R&D. AstraZeneca) ;
Jiang, Yu (Clinical Pharmacology and Quantitative Pharmacology. Clinical Pharmacology and Safety Sciences. BioPharmaceuticals R&D. AstraZeneca) ;
DiGiandomenico, Antonio (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Colbert, Susan (Oncology. US SM&M. AstraZeneca) ;
Vandamme, Drieke (Inserm CIC 1435. CHU) ;
Coenjaerts, Frank (University Medical Center Utrecht) ;
Malhotra-Kumar, Surbhi (University of Antwerp. Laboratory of Medical Microbiology) ;
Timbermont, Leen (University of Antwerp. Laboratory of Medical Microbiology) ;
Oliver, Antonio (Hospital Universitari Son Espases (Palma de Mallorca, Balears)) ;
Barraud, Olivier (INSERM U1092. Centre Hospitalier Universitaire de Limoges. Université Limoges) ;
Bellamy, Terramika (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Bonten, Marc (Julius Center for Health Science and Primary Care. University Medical Center Utrecht. Utrecht University) ;
Goossens, Herman (Laboratory of Medical Microbiology. Vaccine and Infectious Disease Institute. University of Antwerp) ;
Reisner, Colin (DevPro Biopharma) ;
Esser, Mark T. (Clinical Research and Development. Vaccines and Immune Therapies. BioPharmaceuticals R&D. AstraZeneca Biopharmaceuticals) ;
Jafri, Hasan S. (Late-Stage Development. Respiratory and Immunology. BioPharmaceuticals R&D. AstraZeneca) ;
Joannidis, Michael ;
Klimscha, Walter ;
De Waele, Elisabeth ;
Devriendt, Jacques ;
Huberlant, Vincent ;
Depuydt, Pieter ;
Van Boxstael, Sam ;
Peric, Mladen ;
Kopic, Jasminka ;
Hanauer, Michal ;
Hruby, Tomas ;
Sramek, Vladimir ;
Svoboda, Petr ;
Vymazal, Tomas ;
Novacek, Martin ;
Annane, Djillali ;
Mira, Jean-Paul ;
Souweine, Bertrand ;
Dequin, Pierre-François ;
Meziani, Ferhat ;
Stephan, François ;
Nseir, Saad ;
Gibot, Sebastien ;
Schwebel, Carole ;
Plantefeve, Gaetan ;
Diehl, Jean-Luc ;
Richard, Christian ;
Lamer, Christian ;
Klouche, Kada ;
Jaber, Samir ;
Zakynthinos, Epaminondas ;
Filntisis, Georgios ;
Zakynthinos, Spyros ;
Koutsoukou, Antonia ;
Saroglou, Georgios ;
Nikolaou, Charikleia ;
Vlachogianni, Glykeria ;
Pnevmatikos, Ioannis ;
Mandragos, Konstantinos ;
Kremer, Ildiko ;
Rozgonyi, Zsolt Dezso ;
Marjanek, Zsuzsa ;
Martin-Loeches, Ignacio ;
Singer, Pierre ;
Van Heerden, Vernon ;
Carmeli, Yehuda ;
Povoa, Pedro ;
AlvarezSeoane, Antonio ;
Moura, Pedro ;
Gonzalez, Filipe ;
Ramirez, Paula ;
Torres Marti, Antonio ;
Ferrer Roca, Ricard ;
Oteiza, Lorena ;
Escudero, Dolores ;
Piacentini, Enrique ;
Vera-Artazcoz, Paula (Institut d'Investigació Biomèdica Sant Pau) ;
Tamayo, Luis ;
Gonzalez Gallego, Miguel Angel ;
Suberviola Canas, Borja ;
Figueira, Iglesias ;
Leon, Rafael ;
Korten, Volkan ;
Akova, Murat ;
Wyncoll, Duncan ;
Whitehouse, Tony ;
Hopkins, Phil ;
Sim, Malcolm ;
Golan, Yoav ;
Zervos, Marcus ;
Vazquez, Jose ;
Cherabuddi, Kartikeya ;
Smulian, George ;
Rouphael, Nadine ;
Welker, James ;
Sims, Mathew ;
Van Duin, David ;
McCarthy, Todd ;
Polk, Christopher
Background: Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) in preventing PA nosocomial pneumonia was assessed in PA-colonised mechanically ventilated subjects. [...]
2022 - 10.1186/s13054-022-04204-9
Critical Care, Vol. 26 Núm. 1 (december 2022) , p. 355
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