Evidence map›Paper›PMID 42766022›Full record

ArticleIntensive care medicine2026

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.

Louis Mourisse, Marlies Ostermann, Steven Thiessen, Alexander Dumoulin, Alexander P J Vlaar, Eric Hoste, Selim Mosbahi, Antoine Schneider, Alexander Zarbock, Johannes Boehm and 19 more

Registry-linked trialAbstract read
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In one paragraph

Article in Intensive care medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06168799 (Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ilofotase Alfa in Patients at Risk for Renal Damage Following Open Heart Surgery), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06168799 phase2completednot on this map

Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ilofotase Alfa in Patients at Risk for Renal Damage Following Open Heart Surgery

TypeinterventionalSponsorAM-PharmaRan2023 to 2025Enrolled271ConditionsOpen Heart SurgeryArmsIlofotase alfa, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Louis MourisseDepartment of Intensive Care, Radboud University Medical Centre, Nijmegen, the Netherlands.ORCID http://orcid.org/0000-0001-5785-9172
Marlies OstermannDepartment of Critical Care, King's College London, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Steven ThiessenDepartment of Anaesthesiology and Intensive Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium.
Alexander DumoulinDepartment of Intensive Care AZ Delta Roeselare, Roeselare, Belgium.
Alexander P J VlaarDepartment of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology (L.E.I.C.A.) Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.
Eric HosteDepartment of Intensive Care Medicine, Ghent University Hospital, Ghent University, Ghent, Belgium.
Selim MosbahiDepartment of Cardiac Surgery, Inselspital, University Hospital Bern, Bern, Switzerland.
Antoine SchneiderAdult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
Alexander ZarbockDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany.
Johannes BoehmDepartment of Cardiovascular Surgery, Institute Insure, TUM University Hospital - German Heart Center, TUM School of Medicine & Health, Technical University of Munich, Munich, Germany.
Peter RosenbergerDepartment of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen, Tübingen, Germany.
Matthias ThielmannDepartment of Thoracic and Cardiovascular Surgery, West-German Heart & Vascular Center Essen at University Duisburg-Essen, Essen, Germany.
Eric DuboisDepartment of Intensive Care Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.
Jonah Powell-TuckDepartment of Critical Care, King's College London, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Kamran BaigDepartment of Critical Care, King's College London, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Wencke RenetteDepartment of Cardiovascular Sciences, Anesthesiology and Algology, KULeuven, Leuven, Belgium.
Ingrid MeexDepartment of Anaesthesiology and Intensive Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium.
Margreet Klop-RhielDepartment of Critical Care, King's College London, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Krijna OpschoorDepartment of Intensive Care, Amsterdam UMC, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.
Wim VandenbergheDepartment of Intensive Care Medicine, Ghent University Hospital, Ghent University, Ghent, Belgium.
Matthias SiepeDepartment of Cardiac Surgery, Inselspital, University Hospital Bern, Bern, Switzerland.
Christian StraussDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany.
Felix WirthDepartment of Cardiovascular Surgery, Institute Insure, TUM University Hospital - German Heart Center, TUM School of Medicine & Health, Technical University of Munich, Munich, Germany.
Matthias WinkelAM-Pharma BV, Utrecht, the Netherlands.
Liesbeth HofAM-Pharma BV, Utrecht, the Netherlands.
Maarten KraanAM-Pharma BV, Utrecht, the Netherlands.
Juliane BernholzAM-Pharma BV, Utrecht, the Netherlands.
Peter PickkersDepartment of Intensive Care, Radboud University Medical Centre, Nijmegen, the Netherlands. Peter.pickkers@radboudumc.nl.
study team

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAcute 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.

methodsThis 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

resultsIn 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.

conclusionAdministration 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.

trial registrationEUCT Number: 2023-505859-45 US IND Number: 117 605 ClinicalTrials.gov ID: NCT06168799.

Indexed as

Acute kidney injuryCardiac surgeryRenal impairment

Identifiers

PMID42766022

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.