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 - Scorecard - 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 Scorecard: 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

At a Glance

Category

Detail

Condition

Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)

Key Mechanisms

Inflammatory response from surgical procedure and cardiopulmonary bypass.

Target Population

Adults scheduled for complex cardiac surgery at high risk for CSA-AKI.

Care Setting

Cardiothoracic surgery centers

Key Highlights

  • Ilofotase alfa did not reduce postoperative renal impairment compared to placebo.

  • Safety findings were reassuring with no emerging concerns.

  • CSA-AKI occurs in up to 30% of cardiac surgery patients.

  • No pharmacological intervention has been approved for CSA-AKI prevention or treatment.

Guideline-Based Recommendations

Diagnosis

  • Defined according to KDIGO criteria.

Management

  • No approved pharmacological interventions for CSA-AKI.

Monitoring & Follow-up

  • Monitor serum creatinine levels postoperatively.

Risks

  • Increased incidence of chronic kidney disease and mortality associated with CSA-AKI.

Patient & Prescribing Data

Adults (≥ 18 years) with pre-existing renal impairment scheduled for complex cardiac surgery.

Ilofotase alfa administered intravenously before and after surgery.

Clinical Best Practices

  • Assess eGFR prior to surgery using the CKD-EPI equation.

  • Consider risk factors for AKI in surgical planning.

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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