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Study of Ravulizumab to Prevent Delayed Graft Function in Adult Patients After Kidney Transplant

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What is this trial about?

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

This clinical trial focuses on studying Delayed Graft Function, a condition that can occur after kidney transplantation. The study tests a medication called ravulizumab (also known as ALXN1210), which is given through intravenous infusion. Some participants will receive the actual medication, while others will receive a placebo. The purpose is to determine if ravulizumab can reduce the severity of delayed graft function in adults who are at high risk of developing this condition after receiving a kidney from a deceased donor.

The study involves patients who have End-Stage Kidney Disease and require dialysis before their transplant. These patients will be receiving kidneys from deceased donors through either Donation after Circulatory Death or Donation after Brain Death. The treatment involves receiving either ravulizumab or placebo through an intravenous infusion. The medication or placebo will be given to patients who meet specific medical requirements determined by their healthcare providers.

The study will track how long patients need to remain on dialysis after their transplant and monitor their kidney function. Researchers will observe patients for 90 days after their transplant to evaluate how well the treatment works. During this time, they will measure how quickly patients can stop requiring dialysis and how well their new kidney functions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment administration

    You will receive either ravulizumab or a placebo through an IV infusion (medication given directly into your vein)

    This will occur after your kidney transplant procedure

    The treatment is administered as Ultomiris 1,100 mg/11 mL concentrate solution

  2. Step 2

    First week monitoring

    Your kidney function will be closely monitored during the first 7 days after transplant

    If needed, you may receive dialysis treatment (a procedure to filter waste from your blood)

    Medical staff will record if you require any dialysis sessions during this period

  3. Step 3

    90-day follow-up period

    Your progress will be monitored for 90 days after the transplant

    Medical staff will track how long it takes until you no longer need dialysis

    They will measure your kidney function regularly using blood tests

    The number of required dialysis sessions will be recorded

    Your kidney function will be assessed until it reaches a specific level (30 mL/min/1.73 m²)

  4. Step 4

    Study completion

    The study will conclude after the 90-day monitoring period

    Your final kidney function measurements will be recorded

    The total number of dialysis sessions needed during the study will be documented

Who can join the trial?

5 criteria

  • Must be at least 18 years old when signing the consent form
  • Must have End-Stage Kidney Disease (ESKD) that requires regular dialysis treatment (dialysis-dependent). This means your kidneys have stopped working and you need artificial filtering of blood through dialysis
  • Must be qualified to receive a kidney from one of these donor types:
    • Donation after Circulatory Death (DCD) donor - where the organ is donated after the heart has stopped beating
    • High-risk Donation after Brain Death (DBD) donor - where the organ is donated after brain death has been confirmed
    • Both men and women can participate in this study

Who cannot join the trial?

17 criteria

  • Age below 18 years or above 65 years
  • Previous organ transplant recipients
  • Living donor kidney transplant recipients
  • Individuals with known allergies to the study medication (ravulizumab)
  • Patients with active infections or serious medical conditions
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within the past 30 days
  • History of serious adverse reactions to similar medications
  • Inability to comply with study procedures or follow-up visits
  • Significant kidney disease other than the condition leading to transplant
  • Uncontrolled high blood pressure
  • History of blood clotting disorders
  • Active cancer or history of cancer within the past 5 years
  • Severe liver disease
  • Significant heart disease or recent heart attack (within past 6 months)
  • Current substance abuse or addiction
  • Mental conditions that could interfere with providing informed consent
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Investigated drugs

Ravulizumab is a medication given through an intravenous infusion (directly into the vein). It is being studied to help prevent delayed graft function in people who receive kidney transplants from deceased donors. The medication works by targeting part of the body's immune system to protect the newly transplanted kidney. This treatment aims to reduce the need for dialysis after kidney transplantation and help the new kidney start working more quickly.

What is already known about the treatment

Ravulizumab – A monoclonal antibody medication administered intravenously that works by inhibiting the complement protein C5, which plays a role in immune system response. It is being investigated in clinical trials for preventing delayed graft function (DGF) in kidney transplant recipients, particularly those receiving organs from deceased donors. As a complement inhibitor, ravulizumab helps protect the transplanted kidney from immune-mediated damage during the critical early post-transplant period, potentially reducing the need for dialysis after transplantation.

Investigated diseases

Delayed Graft Function - A condition that occurs after kidney transplantation where the newly transplanted kidney does not function properly immediately after surgery. The transplanted kidney temporarily fails to filter blood and produce urine effectively, requiring continued dialysis support in the early post-transplant period. This condition typically develops within the first week after transplantation and is characterized by poor kidney function and reduced urine output. The kidney may take days to weeks to begin functioning properly, during which time the patient requires temporary dialysis support. This condition affects the initial recovery period after kidney transplantation and can impact how quickly the patient regains normal kidney function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517568-48-00Protocol codeALXN1210-DGF-321Estimated enrolment450 patientsSponsorAlexion Pharmaceuticals Inc.

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