A multicenter randomized, double-blinded placebo-controlled phase 2 trial to evaluate safety and efficacy of ilofotase alfa in patients at risk for kidney injury following open heart surgery - Takeaways - MDSpire
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A Phase 2 Multicenter, Double-Blind, Placebo-Controlled Trial Assessing the Safety and Effectiveness of Ilofotase Alfa in Patients Susceptible to Kidney Injury After Open Heart Surgery

  • By

  • Louis Mourisse

  • Marlies Ostermann

  • Steven Thiessen

  • Alexander Dumoulin

  • Alexander P. J. Vlaar

  • Eric Hoste

  • Selim Mosbahi

  • Antoine Schneider

  • Alexander Zarbock

  • Johannes Boehm

  • Peter Rosenberger

  • Matthias Thielmann

  • Eric Dubois

  • Jonah Powell-Tuck

  • Kamran Baig

  • Wencke Renette

  • Ingrid Meex

  • Margreet Klop-Rhiel

  • Krijna Opschoor

  • Wim Vandenberghe

  • Matthias Siepe

  • Christian Strauss

  • Felix Wirth

  • Matthias Winkel

  • Liesbeth Hof

  • Maarten Kraan

  • Juliane Bernholz

  • Peter Pickkers

  • September 21, 2026

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  • 1

    Ilofotase alfa did not significantly reduce postoperative renal impairment or major kidney events in high-risk cardiac surgery patients compared to placebo.

  • 2

    Safety findings for ilofotase alfa were reassuring, with no significant concerns reported during the trial.

  • 3

    Cardiac surgery-associated acute kidney injury (CSA-AKI) occurs in up to 30% of patients and can lead to severe complications and increased mortality.

  • 4

    The trial involved a multicenter, double-blind, placebo-controlled design with patients at elevated risk for CSA-AKI undergoing complex cardiac surgery.

  • 5

    Ilofotase alfa's mechanism involves dephosphorylating compounds to exert a detoxifying function, but it failed to meet primary efficacy endpoints in this trial.

Original Source(s)

A multicenter randomized, double-blinded placebo-controlled phase 2 trial to evaluate safety and efficacy of ilofotase alfa in patients at risk for kidney injury following open heart surgery

  • by Louis Mourisse, Marlies Ostermann, Steven Thiessen, Alexander Dumoulin, Alexander P. J. Vlaar, Eric Hoste, Selim Mosbahi, Antoine Schneider, Alexander Zarbock, Johannes Boehm, Peter Rosenberger, Matthias Thielmann, Eric Dubois, Jonah Powell-Tuck, Kamran Baig, Wencke Renette, Ingrid Meex, Margreet Klop-Rhiel, Krijna Opschoor, Wim Vandenberghe, Matthias Siepe, Christian Strauss, Felix Wirth, Matthias Winkel, Liesbeth Hof, Maarten Kraan, Juliane Bernholz, Peter Pickkers

  • September 21, 2026

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