1. Efficacy and safety of therapeutic alpha-1-microglobulin RMC-035 in reducing kidney injury after cardiac surgery: a multicentre, randomised, double-blind, parallel group, phase 2a trialResearch in context
- Author
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Alexander Zarbock, Tobias E. Larsson, Nicolas Noiseux, C. David Mazer, Johannes Böhm, Maxime Laflamme, Klaus Matschke, Jan Burkert, Benoit de Varennes, Andrej Myjavec, Andreas Böning, Jay L. Koyner, Dan Engelman, Michael Reusch, Matthias Thielmann, Belén Adrio Nazar, Craig Brown, Cara East, Antonino Ginel Iglesias, Sven Helms, David Kress, Andre Lamy, C David Mazer, Guillermo Muniz Albaiceta, Ignacio Munoz Carvajal, Saturo Osaki, Guillermo Reyes Copa, Claudio Ronco, Vincent Scavo, Ryan Shelstad, Madhav Swaminathan, Gabor Szabo, Nicholas Teman, Jan Vojacek, and Thorsten Wahlers
- Subjects
Acute kidney injury ,Cardiac surgery ,Cardiopulmonary bypass ,Reperfusion injury ,Alpha-1-microglobulin ,Medicine (General) ,R5-920 - Abstract
Summary: Background: Cardiac surgery invariably triggers acute kidney stress causing adverse renal outcomes. The AKITA study evaluated the efficacy and safety of RMC-035, a novel analogue of alpha-1-microglobulin, for reducing cardiac surgery-associated kidney injury. Methods: In this randomised double-blind placebo-controlled phase 2a study, we randomly assigned (1:1) adult hospitalised patients undergoing open-chest cardiac surgery at high risk for acute kidney injury (AKI) at 21 sites in North America and Europe to receive either RMC-035 (1.3 or 0.65 mg/kg) or placebo (1:1) for 2 days (5 intravenous infusions), stratified by region and renal function. Eligible patients had at least one pre-defined AKI risk factor. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR]
- Published
- 2024
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