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 - Report - 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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Clinical Report: Safety and Effectiveness of Ilofotase Alfa in Cardiac Surgery

Overview

In a phase 2 trial, ilofotase alfa did not significantly reduce postoperative renal impairment or major kidney events in high-risk cardiac surgery patients compared to placebo.

Background

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common and serious complication, affecting up to 30% of patients undergoing such procedures. It can lead to severe outcomes, including chronic kidney disease and increased mortality. Current preventive strategies lack effective pharmacological interventions.

Data Highlights

No significant reduction in postoperative renal impairment or major kidney events was observed with ilofotase alfa compared to placebo.

Key Findings

  • Ilofotase alfa failed to demonstrate a reduction in postoperative renal impairment in high-risk cardiac surgery patients.
  • No significant differences in major kidney events were noted between ilofotase alfa and placebo groups.
  • Safety findings for ilofotase alfa were reassuring, with no new safety concerns identified.
  • CSA-AKI remains a significant cause of morbidity and mortality in cardiac surgery patients.

Clinical Implications

Clinicians should continue to rely on established preventive strategies.

Conclusion

The phase 2 trial results suggest that ilofotase alfa does not provide a benefit in preventing renal impairment following cardiac surgery.

Related Resources & Content

  1. Intensive Care Medicine, 2023 -- Phase 3 Study of Recombinant Human Alkaline Phosphatase in Patients with Acute Kidney Injury Related to Sepsis (REVIVAL)
  2. The Society of Thoracic Surgeons/Society of Cardiovascular Anesthesiologists/American Society of Extracorporeal Technology Clinical Practice Guidelines for the Prevention of Adult Cardiac Surgery-Associated Acute Kidney Injury - PMC
  3. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial - PMC
  4. Ophthalmology Management — Phase 3 ALTO Trial of KSI-501 Begins Enrollment Recommendations
  5. Retinal Physician — Clinical Trial Update November/December 2023
  6. Retinal Physician — ALTO Trial Tests KSI-501 Against Aflibercept in DME Recommendations
  7. The Society of Thoracic Surgeons/Society of Cardiovascular Anesthesiologists/American Society of Extracorporeal Technology Clinical Practice Guidelines for the Prevention of Adult Cardiac Surgery-Associated Acute Kidney Injury - PMC
  8. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial - PMC
  9. Effect of Human Recombinant Alkaline Phosphatase on 7-Day Creatinine Clearance in Patients With Sepsis-Associated Acute Kidney Injury: A Randomized Clinical Trial - PMC

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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