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

Acute impairment of kidney function after cardiac surgery is common and associated with an increased morbidity and mortality. Ilofotase alfa has demonstrated potential to attenuate renal injury through its immunomodulatory effects. We evaluated the safety and efficacy of ilofotase alfa in preventing renal functional impairment in cardiac surgery patients. This phase 2, multi-center, randomized, double-blinded, placebo-controlled trial employing a two-arm, parallel-group design randomized adult patients at a high risk of renal functional impairment after on-pump cardiac surgery. Patients with a pre-existent estimated glomerular filtration rate of 25–65 ml/min/1.73m 2 scheduled to undergo complex cardiac surgery were eligible. Patients received two intravenous doses (128 mg) of ilofotase alfa or placebo perioperatively. The primary endpoint was the ratio between the highest serum creatinine levels within five days postoperative relative to the pre-operative level (sCrRatio). The secondary endpoint was major adverse kidney events up to day 60 (MAKE60). In total, 244 patients were randomized of whom 204 received two doses and were included in the trial analysis: 109 patients were treated with ilofotase alfa and 95 received placebo. The mean±SD sCrRatio in the ilofotase alfa group was 1.21±0.42, compared to 1.27±0.50 for placebo (p=0.31). MAKE60 incidence was 15.9% in the ilofotase alfa group and 15.4% in the placebo group (p=0.87). No safety concerns were raised. Administration of ilofotase alfa did not attenuate short- and longer-term renal function loss in patients at a high risk of renal functional impairment after on-pump cardiac surgery. No safety concerns of ilofotase alfa emerged. EUCT Number: 2023-505859-45 US IND Number: 117 605 ClinicalTrials.gov ID: NCT06168799

Authors

Institutions

Publication Details

Journal
Intensive Care Medicine
Published
2026-09-21
DOI
https://doi.org/10.1007/s00134-026-08596-y
Primary Topic
Acute Kidney Injury Research
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
article

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

Hendrik Booke, Valbona Mirakaj, Selim Mosbahi, Wolfgang Ristau et al.
Intensive Care Medicine
Acute Kidney Injury Research
article

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

Hendrik Booke, Valbona Mirakaj, Selim Mosbahi, Wolfgang Ristau, Jolien Van Hecke, Wim Vandenberghe, Anouska De Smeytere, Matthias Thielmann, Sabine Hermann, Steven Thiessen, Juliane Bernholz, Ingrid Meex, Matthias Siepe, Alexander P. J. Vlaar, Alexander Dumoulin, MC Kraan, Johannes Boehm, Alice Bernard, Liesbeth Hof, Wencke Renette, Matthias Winkel, Christian Strauß, Katrin Schützenmeister, Louis Mourisse, Peter Pickkers, Felix Wirth, the Study Team, Krijna Opschoor, Eric Hoste, Antoine Schneider, Eric Dubois, Peter Rosenberger, Kamran Baig, Lesley Decoster, Daisy Vermeiren, Jonah Powell-Tuck, Moritz Mertes, Margreet Klop-Rhiel, Alexander Zarbock, Nienke Geelink, Marlies Ostermann
article en

Abstract

Acute impairment of kidney function after cardiac surgery is common and associated with an increased morbidity and mortality. Ilofotase alfa has demonstrated potential to attenuate renal injury through its immunomodulatory effects. We evaluated the safety and efficacy of ilofotase alfa in preventing renal functional impairment in cardiac surgery patients. This phase 2, multi-center, randomized, double-blinded, placebo-controlled trial employing a two-arm, parallel-group design randomized adult patients at a high risk of renal functional impairment after on-pump cardiac surgery. Patients with a pre-existent estimated glomerular filtration rate of 25–65 ml/min/1.73m 2 scheduled to undergo complex cardiac surgery were eligible. Patients received two intravenous doses (128 mg) of ilofotase alfa or placebo perioperatively. The primary endpoint was the ratio between the highest serum creatinine levels within five days postoperative relative to the pre-operative level (sCrRatio). The secondary endpoint was major adverse kidney events up to day 60 (MAKE60). In total, 244 patients were randomized of whom 204 received two doses and were included in the trial analysis: 109 patients were treated with ilofotase alfa and 95 received placebo. The mean±SD sCrRatio in the ilofotase alfa group was 1.21±0.42, compared to 1.27±0.50 for placebo (p=0.31). MAKE60 incidence was 15.9% in the ilofotase alfa group and 15.4% in the placebo group (p=0.87). No safety concerns were raised. Administration of ilofotase alfa did not attenuate short- and longer-term renal function loss in patients at a high risk of renal functional impairment after on-pump cardiac surgery. No safety concerns of ilofotase alfa emerged. EUCT Number: 2023-505859-45 US IND Number: 117 605 ClinicalTrials.gov ID: NCT06168799

Intensive Care Medicine
Radboud University Nijmegen (NL), King's College London (GB), Guy's and St Thomas' NHS Foundation Trust (GB), University Hospital of Bern (CH), Ghent University Hospital (BE), Erasmus MC (NL), Centre Hospitalier Universitaire Vaudois (CH), Radboud University Medical Center (NL), University Hospital Münster (DE), Inagro (Belgium) (BE), AM–Pharma (Netherlands) (NL), AZ Delta (BE), Deutsches Herzzentrum München (DE), Ziekenhuis Oost-Limburg (BE), Amsterdam University Medical Centers (NL), West German Heart and Vascular Center Essen (DE), University of Tübingen (DE), Hasselt University (BE), KU Leuven (BE)
Good health and well-being
Openalex Percentile: Top 11%
Acute Kidney Injury Research
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.