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Study on Ravulizumab for Protecting Chronic Kidney Disease Patients from Acute Kidney Injury After Heart Surgery

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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 with Chronic Kidney Disease (CKD) who are undergoing heart surgery. The study aims to explore the effectiveness of a treatment called ravulizumab, also known by its code name ALXN1210, in preventing kidney problems that can occur after heart surgery. These kidney problems are known as Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and can lead to more serious kidney issues called Major Adverse Kidney Events (MAKE).

The study will compare the effects of ravulizumab with a placebo, which is a substance with no active medication. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The goal is to see if ravulizumab can reduce the risk of kidney problems after surgery. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Participants in the study will be monitored over a period of time to assess the impact of the treatment on their kidney health. The study will track various outcomes, including the occurrence of kidney injury and recovery, as well as overall health and any side effects. The findings from this study could provide valuable insights into improving care for patients with CKD undergoing heart surgery.

The research process

The trial runs in 7 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, you will be asked to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate. It includes details about the study's requirements and restrictions.

  2. Step 2

    Initial assessment

    You will undergo an initial assessment to confirm your eligibility. This includes checking your age, weight, and medical history related to chronic kidney disease and planned cardiac surgery. Your kidney function will be evaluated using specific tests.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the study medication, ravulizumab, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you receive.

  4. Step 4

    Medication administration

    If you are assigned to the ravulizumab group, you will receive the medication through an intravenous (IV) infusion. The dosage is 300 mg/30 mL, and the frequency and duration will be determined by the study protocol.

  5. Step 5

    Surgery and monitoring

    You will undergo your planned cardiac surgery. After the surgery, your kidney function and overall health will be closely monitored. This includes regular assessments to check for any signs of acute kidney injury or other adverse events.

  6. Step 6

    Follow-up visits

    You will have follow-up visits at specified intervals, such as days 30, 60, and 90 after the surgery. During these visits, your kidney function and general health will be evaluated. You may also be asked to complete questionnaires about your quality of life and fatigue levels.

  7. Step 7

    Study completion

    At the end of the study period, your participation will conclude. You will have a final assessment to review your health status and any changes since the beginning of the study.

Who can join the trial?

11 criteria

  • Must be between 18 and 90 years old at the time of signing the consent form.
  • Can be male or female. Female participants who can have children and male participants must follow specific birth control guidelines.
  • Must have a body weight of at least 30 kg (about 66 pounds) at the time of screening.
  • Must be scheduled for planned, non-emergency heart surgery that requires a heart-lung machine. This includes:
    • Multiple blood vessel bypass surgery (CABG)
    • Heart valve replacement or repair
    • Surgery on the ascending aorta if combined with aortic valve replacement/repair
    • Combined CABG and valve surgery
    • Single-vessel CABG when combined with valve replacement/repair
    • Must have chronic kidney disease (CKD) or be suspected to have it, with specific kidney function test results (eGFR between 20 to less than 60 mL/min/1.73 m²).
    • Must be at risk for kidney problems after surgery, with a minimum risk score of 2.8% as assessed at screening.
    • Must be able to give signed informed consent and agree to follow the study requirements and restrictions.

Who cannot join the trial?

9 criteria

  • Patients who have a known allergy or sensitivity to the study medication or its ingredients.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe allergic reactions, known as **anaphylaxis**, to any medication.
  • Patients with a current or recent infection that requires treatment with antibiotics.
  • Patients with a history of certain types of cancer, unless they have been in remission for a specified period.
  • Patients with severe liver disease or liver function impairment.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who are pregnant or breastfeeding.
  • Patients with any other medical condition that the study doctors believe would make participation unsafe or affect the study results.
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Investigated drugs

Ravulizumab is a medication being studied for its potential to protect the kidneys during heart surgery. It is designed to help prevent acute kidney injury, which can happen when the kidneys are stressed during surgery. This medication works by blocking a part of the immune system that can cause inflammation and damage to the kidneys. The goal of using ravulizumab in this trial is to see if it can reduce the risk of kidney problems after surgery and improve overall kidney health in patients with chronic kidney disease.

What is already known about the treatment

Ravulizumab – Ravulizumab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials for its potential to prevent acute kidney injury in patients undergoing cardiac surgery, particularly those with chronic kidney disease. The medication works by inhibiting a part of the immune system called the complement system, which can cause inflammation and damage to the kidneys. Ravulizumab is classified as a monoclonal antibody, a type of drug designed to target specific proteins in the body.

Investigated diseases

Acute Kidney Injury – Acute Kidney Injury (AKI) is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. AKI can occur due to a variety of reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. The condition can lead to a decrease in urine output, swelling in the legs, ankles, and around the eyes, and fatigue. As AKI progresses, it can cause complications such as fluid retention, electrolyte imbalances, and increased pressure in the blood vessels. Recovery from AKI can vary, with some individuals experiencing full recovery while others may have lasting kidney damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501802-36-00Protocol codeALXN1210-CSA-AKI-318Estimated enrolment750 patientsSponsorAlexion Pharmaceuticals Inc.

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