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Study of RMC-035 to prevent kidney injury in patients undergoing open-chest heart surgery

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What is this trial about?

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

This study focuses on preventing kidney injury in patients who undergo open-chest cardiac surgery. The research evaluates a new medication called RMC-035 (also known as ROSgard), which is given through an infusion. The medication is being tested to see how well it can protect kidney function in patients who are at high risk of developing kidney problems after heart surgery.

The study involves testing different doses of RMC-035 compared to placebo to find the most effective amount of medication for protecting kidney function. During the study, participants will receive either RMC-035 or placebo through an infusion into their veins. The maximum daily dose will be 120 milligrams, and the total treatment period will last up to 2 days.

After receiving the treatment, patients will be monitored for changes in their kidney function, particularly focusing on how well their kidneys are working 90 days after surgery. The medication being tested is a biological product that contains a modified version of a protein naturally found in the body. This protein has protective properties that may help prevent kidney damage during and after 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

    Initial screening

    Your kidney function will be measured using a blood test to calculate eGFR (estimated glomerular filtration rate).

    A pregnancy test will be performed if you are a woman who can become pregnant.

    Your medical history will be reviewed to confirm your eligibility for the study.

  2. Step 2

    Preparation for cardiac surgery

    You will be scheduled for a planned (non-emergency) open-chest cardiac surgery.

    The surgery may include coronary bypass, heart valve repair/replacement, or ascending aorta surgery.

    The surgery will use a heart-lung machine (cardiopulmonary bypass).

  3. Step 3

    Study medication administration

    You will receive either RMC-035 (study medication) or placebo through an IV infusion.

    The medication is a clear, colorless to slightly yellow solution given as an infusion into your vein.

    You will not know whether you receive the actual medication or placebo.

  4. Step 4

    Follow-up period

    Your kidney function will be monitored regularly after surgery.

    The main assessment of your kidney function will occur at Day 90 after surgery.

    You will need to use appropriate contraception during the study and for 7 days after the last dose of study medication.

  5. Step 5

    Study completion

    The study will evaluate how well the medication protects kidney function after cardiac surgery.

    Your participation will help determine the optimal dose of RMC-035 for future patients.

    The study is expected to continue until November 2025.

Who can join the trial?

15 criteria

  • Must be between 18 and 84 years old
  • Must have adequate kidney function with eGFR of at least 30 ml/min/1.73m2 (eGFR is a blood test that measures how well your kidneys are working)
  • Must be scheduled for planned (non-emergency) heart surgery with cardiopulmonary bypass, including:
    • Coronary artery bypass surgery
    • Heart valve surgery
    • Surgery for an enlarged aorta
    • Must have specific risk factors for kidney problems, including either:
      • Reduced kidney function (eGFR less than 60)
      • Combined surgeries with at least one additional risk factor
      • Single surgery with at least two additional risk factors like: heart problems, diabetes, age over 70, previous heart surgery, anemia, or previous kidney problems
      • For women:
        • Must not be pregnant or breastfeeding
        • Must use effective birth control if able to become pregnant
        • Must agree not to donate eggs during the study and for 7 days after
        • For men:
          • Must agree not to donate sperm during the study and for 7 days after
          • Must use appropriate contraception or abstain from sexual activity
          • Must be able to understand and sign the informed consent form
          • Must agree not to participate in other clinical trials during the study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 85 years
  • Known severe allergic reactions to medications
  • Current participation in other clinical trials
  • Presence of chronic kidney disease (long-term kidney problems)
  • Pregnancy or breastfeeding
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • Recent heart attack (within last 30 days)
  • Active infection or fever
  • Blood clotting disorders or current use of blood thinners
  • History of organ transplantation
  • Severe liver disease
  • Autoimmune diseases (conditions where the immune system attacks the body)
  • Active cancer or ongoing cancer treatment
  • Inability to provide informed consent
  • Severe mental health conditions that could affect participation
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Investigated drugs

RMC-035 is an investigational medication being studied to protect kidney function in patients who undergo open-chest cardiac surgery. This medication is designed to reduce the risk of kidney injury that can occur during and after heart surgery. It works to help maintain proper kidney function and may provide long-term kidney protection for patients who are at high risk of developing kidney problems following their cardiac surgery.

What is already known about the treatment

RMC-035 – An investigational drug being studied in Phase 2b clinical trials for preventing kidney injury in patients undergoing open-chest cardiac surgery. The medication is designed to protect renal function in high-risk patients, with particular focus on long-term kidney protection up to 90 days after surgery. While the exact mechanism of action is still under investigation as part of the clinical trial process, this drug is being evaluated through a placebo-controlled, double-blind study to determine its optimal dosing and efficacy in preserving kidney function following cardiac surgical procedures.

Investigated diseases

  • Acute Kidney Injury After Cardiac Surgery

    A condition where kidney function suddenly declines following heart surgery procedures. It occurs when the kidneys are damaged during or after cardiac surgery, leading to a decrease in their ability to filter waste products from blood. The condition typically develops within the first few days after surgery and can be identified through changes in urine output and blood tests. This type of kidney injury can affect the body's ability to maintain proper fluid balance and remove waste products. The condition may be temporary, with kidney function gradually improving over time.

  • Cardiac Surgery-Associated Acute Kidney Injury

    A specific form of kidney damage that develops as a complication of cardiac surgical procedures. The condition occurs when the kidneys experience stress during or after heart surgery, resulting in decreased kidney function and reduced ability to filter blood. It can develop due to changes in blood flow during surgery, inflammatory responses, and other surgery-related factors. The severity can range from mild kidney function decline to more significant impairment. This condition can affect fluid balance and waste removal in the body.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510658-28-00Protocol code24-ROS-07Estimated enrolment180 patientsSponsorGuard Therapeutics International AB (publ)

sourced from the EU Clinical Trials Register and site verification

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