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Can a protein shield your kidneys during Open-Heart surgery?

NCT ID NCT06475274

Disease control Sponsor: Guard Therapeutics AB 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called RMC-035 in 170 adults at high risk for kidney injury after open-chest heart surgery. Participants received three doses of the drug or a placebo during and after surgery. Researchers measured kidney function at 90 days to see if the drug helps protect the kidneys and is safe.

What this could mean

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

Active substance
RMC-035 (a protein given by IV infusion)
What this could lead to
If it works, this could point toward a treatment to protect kidneys from damage after heart surgery.
What could go wrong
This is a phase 2b dose-finding study with only 170 participants, so results are preliminary. The drug may not improve kidney function or could cause unexpected 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

170 people

The number who actually took part.

Started

Aug 2024

Finished

Sep 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 to 84 years

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: * eGFR ≥30 ml/min/1.73m2 * Scheduled for non-emergent surgery of any of the following types, with use of cardiopulmonary bypass (CPB): coronary artery bypass grafting (CABG), valve surgery, ascending aorta aneurysm surgery * Risk factors for acute kidney injury are present * Participant capable of providing written informed consent * Participant agrees to study restrictions such as not to take part in another interventional study, use contraception and not donate ova or sperm Exclusion Criteria: * Any medical condition that makes the participant unsuitable * Scheduled for emergent surgeries * Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries * Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), or off-pump surgeries or left ventricular assist device (LVAD) implantation * Experiences a cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices such as intraaortic balloon pumping (IABP) within 24 hours prior to surgery * Requires any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support. * Diagnosed with AKI prior to surgery * Requires cardiopulmonary resuscitation prior to surgery * Ongoing sepsis or an untreated diagnosed clinically significant infection * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3.0 times the upper limit of normal (ULN). * Total bilirubin ≥2.0 time ULN * History of solid organ transplantation * History of renal replacement therapy * Severe allergic asthma * Chronic immunosuppressive treatment that may have an impact on kidney function * Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function * Current enrolment or past recent participation in any other clinical study involving an investigational study treatment * Previously treatment of RMC-035 * Sensitivity to any of the study interventions, or components thereof

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

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

Kidney injury following open-chest cardiac surgery

Contacts and locations

Locations

  • Research site 1

    Toronto, Canada

  • Research site 1

    Hradec Králové, Czechia

  • Research site 1

    Münster, Germany

  • Research site 1

    Madrid, Spain

  • Research site 2

    Québec, Canada

  • Research site 2

    Prague, Czechia

  • Research site 2

    München, Germany

  • Research site 2

    Madrid, Spain

  • Research site 3

    Saint John, Canada

  • Research site 3

    Essen, Germany

  • Research site 3

    Barcelona, Spain

  • Research site 4

    Montreal, Canada

  • Research site 4

    Halle, Germany

  • Research site 4

    Córdoba, Spain

  • Research site 5

    Montreal, Canada

  • Research site 5

    Dresden, Germany

  • Research site 5

    Santiago de Compostela, Spain

  • Research site 6

    Giessen, Germany

  • Research site 6

    Pamplona, Spain