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

Intensive Care Medicine

Objective:

To evaluate the safety and efficacy of ilofotase alfa for preventing cardiac surgery-associated acute kidney injury (CSA-AKI) and related kidney events.

Approach:

Trial Design: This phase 2, randomized, double-blind, placebo-controlled trial was conducted at multiple European cardiothoracic surgery centers.
Patient Selection: The trial enrolled adults scheduled for cardiac surgery who were considered at increased risk of CSA-AKI. The findings apply to the population enrolled and may not generalize to all cardiac surgery patients.
Intervention: Participants received two intravenous doses of ilofotase alfa (128 mg per dose) or placebo around the time of surgery.
Outcome Measures: The primary endpoint was the ratio of the highest postoperative serum creatinine to the preoperative baseline serum creatinine.

Key Findings:

The trial did not demonstrate a statistically significant benefit of ilofotase alfa over placebo on the primary endpoint.
The results did not establish a reduction in major kidney events.
No significant safety concerns were reported in the trial.

Interpretation:

Ilofotase alfa did not meet the trial’s primary efficacy endpoint. These phase 2 results do not establish that the treatment prevents CSA-AKI in the studied population.

Limitations:

The findings are specific to the trial population, design, and outcomes and may not apply to other patient groups or settings.
Further research would be needed to determine whether ilofotase alfa has a role in preventing kidney injury after cardiac surgery.

Conclusion:

In this phase 2 trial, ilofotase alfa did not demonstrate a significant benefit on the primary measure of postoperative renal impairment compared with placebo.