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Study on Ilofotase Alfa to Prevent Kidney Damage in Patients Undergoing Open Heart Surgery

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who are at risk of developing renal damage after undergoing open heart surgery. The study is investigating a treatment called Ilofotase alfa, which is given as a concentrate for solution for infusion, meaning it is administered directly into the bloodstream through a vein. The purpose of the study is to evaluate how effective and safe Ilofotase alfa is in protecting the kidneys during and after heart surgery.

Participants in the trial will be randomly assigned to receive either Ilofotase alfa or a placebo, which is a substance with no active medication. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will monitor the participants' kidney function by measuring levels of a substance called serum creatinine, which is a marker of kidney health, before and after the surgery.

Throughout the study, the safety of the participants will be closely monitored, and any side effects or adverse events will be recorded. The trial will also collect information on how the body processes Ilofotase alfa, known as pharmacokinetics. The study is expected to continue until 2025, with the aim of providing valuable insights into the potential benefits of Ilofotase alfa for patients undergoing heart surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, planned type of heart surgery, and kidney function.

    Participants must be at least 18 years old and scheduled for certain types of open-heart surgery using a heart-lung machine.

  2. Step 2

    Pre-surgery assessment

    Before surgery, a baseline measurement of serum creatinine, a marker of kidney function, is taken.

    This measurement helps to compare kidney function before and after surgery.

  3. Step 3

    Administration of ilofotase alfa or placebo

    Participants receive either ilofotase alfa or a placebo through an intravenous infusion.

    The medication is given as a concentrate for solution, specifically designed for infusion.

  4. Step 4

    Post-surgery monitoring

    After surgery, kidney function is monitored by measuring serum creatinine levels on days 1, 2, 3, 4, and 5.

    The goal is to assess any changes in kidney function compared to the baseline measurement.

  5. Step 5

    Follow-up period

    Participants are monitored for any adverse events or side effects until day 28 after surgery.

    This period includes tracking the incidence of any health issues that may arise.

Who can join the trial?

7 criteria

  • Must be **18 years or older**.
  • Scheduled for specific types of **open chest heart surgery** using a machine that helps circulate blood during the operation. This includes:
    • Combined valve and CABG surgery (a type of heart surgery).
    • Aortic valve plus aortic root and/or ascending aorta surgery (excluding aortic arch).
    • CABG with 3 or more connections to blood vessels.
    • Have a **screening eGFR** (a test that measures kidney function) between **25 and 65 mL/min/1.73m²**. This is calculated using a blood test that can be up to 28 days old.
    • Female patients who can have children must agree to use an effective **birth control method** during the treatment and for 14 days after. Women who are post-menopausal (over 60 years old or haven't had a period for 12 months without another medical reason) do not need to use birth control.
    • Male patients must agree not to donate sperm and to use a **male condom** during sexual intercourse. If their partner can have children, they must also agree to use an effective birth control method during the treatment and for 14 days after.

Who cannot join the trial?

6 criteria

  • Patients who have a known allergy or bad reaction to the study medication or any of its ingredients.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients with severe liver disease, which means the liver is not working properly.
  • Patients with a history of drug or alcohol abuse, which means using drugs or alcohol in a harmful way.
  • Patients who are pregnant or breastfeeding, as the study medication might affect the baby.
  • Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
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Investigated drugs

Ilofotase Alfa is a medication being studied for its potential to protect kidney function in patients who are at risk of kidney damage after undergoing open heart surgery. The trial aims to evaluate how effective and safe this medication is in preventing or reducing kidney problems in these patients.

What is already known about the treatment

Ilofotase Alfa – Ilofotase Alfa is administered intravenously, typically during or after open heart surgery, to patients at risk of kidney damage. It is currently being studied in clinical trials to evaluate its effectiveness and safety, with a focus on improving kidney function. The main therapeutic indication is to prevent renal damage in patients undergoing open heart surgery. At the molecular level, Ilofotase Alfa works by breaking down harmful substances that can accumulate in the kidneys, thereby protecting kidney cells. It is classified pharmacologically as an enzyme replacement therapy.

Investigated diseases

Risk for Renal Damage Following Open Heart Surgery – This condition involves the potential for kidney injury that can occur after undergoing open heart surgery. During such surgeries, the kidneys may be affected due to changes in blood flow, inflammation, or other stressors related to the procedure. The risk is often monitored by measuring levels of serum creatinine, a waste product filtered by the kidneys, to assess kidney function. An increase in serum creatinine levels post-surgery can indicate that the kidneys are not functioning properly. This condition requires careful monitoring to prevent further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505859-45-00Protocol codeAP-recAP-CSA-RD-0201Estimated enrolment250 patientsSponsorAM-Pharma B.V.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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