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

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

Purpose Ilofotase alfa is a human recombinant alkaline phosphatase with reno-protective effects that showed improved survival and reduced Major Adverse Kidney Events by 90 days (MAKE90) in sepsis-associated acute kidney injury (SA-AKI) patients. REVIVAL, was a phase-3 trial conducted to confirm its...

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Veröffentlicht in:Intensive care medicine 2024, Vol.50 (1), p.68-78
Hauptverfasser: Pickkers, Peter, Angus, Derek C., Bass, Kristie, Bellomo, Rinaldo, van den Berg, Erik, Bernholz, Juliane, Bestle, Morten H., Doi, Kent, Doig, Chistopher J., Ferrer, Ricard, Francois, Bruno, Gammelager, Henrik, Pedersen, Ulf Goettrup, Hoste, Eric, Iversen, Susanne, Joannidis, Michael, Kellum, John A., Liu, Kathleen, Meersch, Melanie, Mehta, Ravindra, Millington, Scott, Murray, Patrick T., Nichol, Alistair, Ostermann, Marlies, Pettilä, Ville, Solling, Christoffer, Winkel, Matthias, Young, Paul J., Zarbock, Alexander
Format: Artikel
Sprache:eng
Schlagworte:
Acute Kidney Injury - drug therapy
Acute Kidney Injury - etiology
Alkaline phosphatase
Alkaline Phosphatase - therapeutic use
Analysis
Anesthesiology
Care and treatment
Critical Care Medicine
Effectiveness
Emergency Medicine
Health aspects
Health care industry
Humans
Infection
Intensive
Intensive care
Intensive Care Units
Kidneys
Medical equipment and supplies industry
Medical test kit industry
Medicine
Medicine & Public Health
Mortality
NCT
NCT04411472
Original
Pain Medicine
Pediatrics
Pharmaceutical industry
Phosphatase
Phosphatases
Placebos
Pneumology/Respiratory System
Product development
Safety
Sepsis
Sepsis - complications
Sepsis - drug therapy
Statistical analysis
Survival
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Zusammenfassung:Purpose Ilofotase alfa is a human recombinant alkaline phosphatase with reno-protective effects that showed improved survival and reduced Major Adverse Kidney Events by 90 days (MAKE90) in sepsis-associated acute kidney injury (SA-AKI) patients. REVIVAL, was a phase-3 trial conducted to confirm its efficacy and safety. Methods In this international double-blinded randomized-controlled trial, SA-AKI patients were enrolled 
ISSN:0342-4642
1432-1238
DOI:10.1007/s00134-023-07271-w