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Can a simple infusion shield kidneys during heart surgery?

NCT ID NCT06168799

Disease control Sponsor: AM-Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a drug called ilofotase alfa can prevent kidney damage in people undergoing open heart surgery. 271 patients received either the drug or a placebo before and after surgery. The goal was to see if the drug could keep kidney function stable and reduce serious kidney events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ilofotase alfa
What this could lead to
If it works, this could provide a way to protect kidneys during heart surgery, reducing the risk of long-term kidney problems.
What could go wrong
This is a Phase 2 trial with only 271 participants, so results may not apply to everyone. The drug may not prove effective or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

271 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years 2. Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB): 1. 1\. combined valve and CABG surgery; 2. aortic valve plus aortic root and/or ascending aorta (excluding aortic arch) 2. CABG with 3 or more distal anastomoses 3. Screening eGFR ≥25 mL/min/1.73m2 and ≤65 mL/min/1.73m2 4. Female patients of childbearing potential agreeing to use effective contraception within IP treatment and 14 days thereafter Post-menopausal females do not require contraception during the trial. 5. Male patients agreeing to refrain from donating sperm, use a male condom when having sexual intercourse and in case their partner is of childbearing potential they must agree to use adequate and effective contraception method (see inclusion criterion 4) within IP treatment and 14 days thereafter The five most important Exclusion Criteria: 1. Body weight ≤55 kg 2. Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis 3. Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery 4. Known chronic liver disorder with Child-Pugh C classification 5. Current planned (or scheduled) surgical intervention under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest

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Conditions

The condition(s) this trial relates to.

acute kidney injury prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Open heart surgery

Contacts and locations

Locations

  • Research site

    Munich, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.