Currently submitted to: JMIR Research Protocols
Date Submitted: May 13, 2026
Open Peer Review Period: May 13, 2026 - Jul 8, 2026
(closed for review but you can still tweet)
NOTE: This is an unreviewed Preprint
Warning: This is a unreviewed preprint (What is a preprint?). Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note "no longer under consideration" will appear above).
Peer review me: Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period (in this case, a "Peer Review Me" button to sign up as reviewer is displayed above). All preprints currently open for review are listed here. Outside of the formal open peer-review period we encourage you to tweet about the preprint.
Citation: Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).
Final version: If our system detects a final peer-reviewed "version of record" (VoR) published in any journal, a link to that VoR will appear below. Readers are then encourage to cite the VoR instead of this preprint.
Settings: If you are the author, you can login and change the preprint display settings, but the preprint URL/DOI is supposed to be stable and citable, so it should not be removed once posted.
Submit: To post your own preprint, simply submit to any JMIR journal, and choose the appropriate settings to expose your submitted version as preprint.
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Study protocol for a multicentre randomised, 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
ABSTRACT
Background:
Acute kidney injury (AKI) is a common and serious complication following cardiothoracic surgery, occurring in up to 30% of patients. Cardiac surgery-associated AKI (CSA-AKI) is associated with increased morbidity, mortality, and progression to chronic kidney disease. Currently, no pharmacological interventions have been approved for clinical use to reduce the incidence or severity of CSA-AKI. It is hypothesized that early modulation of the inflammatory response, triggered by the release of damage-associated molecular patterns during surgery, may improve renal outcomes. Ilofotase alfa, a recombinant human alkaline phosphatase, has demonstrated potential to attenuate renal injury through its immunomodulatory effects in animal studies.
Objective:
This manuscript presents the protocol for a Phase 2 clinical trial evaluating the safety and efficacy of ilofotase alfa in preventing renal damage following cardiac surgery.
Methods:
This is a Phase 2, multi-centre, randomized, double-blinded, placebo-controlled trial employing a two-arm, parallel-group design. Adult patients at risk for CSA-AKI undergoing complex open-heart surgery will be randomized to receive two intravenous doses (2x128 mg) of ilofotase alfa or placebo, just before and after surgery. Ethics and Dissemination The study has been approved by all relevant institutional review boards and independent ethics committees. It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and all applicable regulatory requirements. The results of this trial will inform the potential role of ilofotase alfa in preventing cardiac surgery associated renal injury and improving longer-term clinical outcomes and will be published in a peer-reviewed scientific journal.
Results:
The primary endpoint is the serum creatinine ratio, defined as the highest serum creatinine level within five days postoperatively relative to the preoperative baseline, with the occurrence of major adverse kidney events up to day 60 as the secondary endpoint. In addition, safety assessments and the AKI as defined by the KDIGO creatinine-criterion will be assessed. Patients will be followed for a total of 60 days.
Conclusions:
The results of this study will will enable us to assess safety as well as the efficacy of ilofotase alfa in attenuating renal injury and improving long-term renal outcomes. Clinical Trial: Trial registration numbers EUCT Number:2023-505859-45 US IND Number:117 605 ClinicalTrials.gov ID:NCT06168799
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.