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Study on Imlifidase for Highly Sensitized Patients with End-Stage Chronic Kidney Disease Awaiting Transplant

Verified siteRegistered drugNo placebo
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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 end-stage chronic kidney disease who are highly sensitized and awaiting a kidney transplant. These patients have a high level of antibodies that can make it difficult to find a compatible donor. The study is investigating the use of a treatment called imlifidase, which is designed to temporarily remove these antibodies, allowing for a successful kidney transplant from a deceased donor.

The purpose of the study is to determine the effectiveness and safety of imlifidase in enabling kidney transplants for these patients. Participants will receive the treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will follow patients for one year after their transplant to monitor their health and the success of the transplant.

Throughout the study, researchers will assess various health indicators, such as kidney function and patient survival, to understand the impact of imlifidase. The study will also compare results with other groups of patients who have received kidney transplants without this treatment. This research aims to provide valuable insights into improving transplant outcomes for patients with high antibody levels.

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, eligibility is confirmed based on specific criteria such as age, medical condition, and transplant status.

    Informed consent is obtained, ensuring understanding and agreement to participate in the study.

  2. Step 2

    Pre-treatment assessment

    A positive crossmatch test is conducted to confirm the presence of antibodies against the donor's kidney.

    Baseline measurements are taken, including kidney function and antibody levels.

  3. Step 3

    Imlifidase treatment

    The medication Idefirix, containing imlifidase, is administered through an intravenous infusion.

    The goal of this treatment is to temporarily remove antibodies, allowing for a successful kidney transplant.

  4. Step 4

    Post-treatment monitoring

    Within 24 hours, a follow-up crossmatch test is performed to ensure the antibodies have been effectively reduced.

    Regular monitoring of kidney function and antibody levels occurs at several intervals, including 24 hours, 2 weeks, and 1, 3, 6, and 12 months after treatment.

  5. Step 5

    Kidney transplantation

    Once the crossmatch test is negative, the kidney transplant from a deceased donor is performed.

    The transplant aims to improve kidney function and overall health.

  6. Step 6

    Post-transplant care

    After transplantation, ongoing assessments of kidney function and patient health are conducted.

    Immunosuppressive medications are administered to prevent rejection of the new kidney.

  7. Step 7

    Long-term follow-up

    The study continues to monitor the patient's health and kidney function for up to one year after transplantation.

    The primary goal is to ensure graft survival and patient well-being without significant complications.

Who can join the trial?

14 criteria

  • Must be a male or female patient aged between 18 and 75 years.
  • Must have an acceptable kidney transplant from a deceased donor.
  • Must have end-stage renal disease, which means the kidneys are no longer working well enough to meet the body's needs.
  • Must have been transplanted in Europe after January 1, 2010, and included in the CTS registry, which is a database for tracking transplants.
  • Must have a PRA (Panel Reactive Antibody) of 50% or higher. PRA is a measure of how likely the body is to reject a transplanted organ.
  • Must be on maintenance immunosuppression, which means taking medications to prevent the body from rejecting the transplanted kidney. These medications include a calcineurin inhibitor, mycophenolate mofetil (MMF), and corticosteroids.
  • Must have an ABO-compatible deceased donor aged between 10 and 70 years. ABO compatibility means the blood types of the donor and recipient are compatible.
  • Must be active on the renal transplant waiting list of a kidney allocation system at the time of screening.
  • Must have high sensitisation, meaning the body is more likely to reject a transplant, and have a high unmet medical need, making it unlikely to receive a transplant under the current system.
  • Must have known DSA (Donor-Specific Antibodies) against an available deceased donor. DSA are antibodies that can attack the transplanted organ.
  • Must have a positive crossmatch test, which means the body has antibodies that react against the donor's cells.
  • Must have signed an informed consent form before any trial-related procedures. This means agreeing to participate in the study after understanding all the details.
  • Must be willing and able to follow the study protocol, which includes all the rules and procedures of the trial.
  • Must be active on the renal transplant waiting list at a participating trial site at the time of screening.

Who cannot join the trial?

5 criteria

  • Patients who are not on the kidney transplant list.
  • Patients who are not highly sensitised. This means their immune system is not highly reactive to potential donor kidneys.
  • Patients who do not have end-stage chronic kidney disease. This is the last stage of kidney disease where the kidneys can no longer function on their own.
  • Patients who are not awaiting a kidney transplant.
  • Patients who cannot be pre-treated with a specific medication called imlifidase. This medication is used to help make a donor kidney more compatible with the patient.
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Investigated drugs

Imlifidase is a medication used in this clinical trial to help patients who are highly sensitized and waiting for a kidney transplant. It works by breaking down certain antibodies in the body that can cause the immune system to reject a transplanted kidney. This treatment is given before the transplant to improve the chances of the body accepting the new kidney.

What is already known about the treatment

Imlifidase – Imlifidase is administered intravenously and is used to help patients who are highly sensitized and awaiting a kidney transplant. It is currently being studied in clinical trials to assess its effectiveness and safety in these patients. The main therapeutic indication is for end-stage chronic kidney disease patients who have a positive crossmatch against a deceased donor. Imlifidase works by breaking down antibodies that can cause rejection of the transplanted kidney. It is classified as an enzyme that specifically targets and cleaves immunoglobulin G (IgG) antibodies.

Investigated diseases

End Stage Chronic Kidney Disease – This is the final stage of chronic kidney disease where the kidneys have lost nearly all their ability to function effectively. As the disease progresses, waste products and excess fluids build up in the body, leading to symptoms such as fatigue, swelling, and difficulty concentrating. Patients often require dialysis or a kidney transplant to manage the condition. The disease can develop over many years, often as a result of conditions like diabetes or high blood pressure. In this stage, the kidneys' filtering capacity is severely reduced, typically to less than 15% of normal function. This condition is considered rare when it involves patients who are highly sensitized and awaiting a kidney transplant.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511810-18-00Protocol code20-HMedIdeS-19Estimated enrolment150 patientsSponsorHansa Biopharma AB

sourced from the EU Clinical Trials Register and site verification

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