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Long-Term Follow-Up Study of Imlifidase in Highly Sensitized Kidney Transplant Patients

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 focuses on patients who have undergone a kidney transplantation. The study involves a treatment called Idefirix, which contains the active substance imlifidase. Imlifidase is a protein that helps in preparing patients for kidney transplants by reducing certain antibodies that can cause complications. The trial includes two groups: patients who are highly sensitized, meaning they have a high level of antibodies that can make finding a compatible kidney difficult, and a reference group of less sensitized patients who received a compatible kidney transplant.

The purpose of the study is to observe the long-term outcomes of patients who received imlifidase before their kidney transplant. The study will follow these patients over several years to see how well their transplanted kidneys function and to monitor their overall health. This includes checking for any signs of the body rejecting the new kidney, which is known as graft failure, and assessing kidney function through tests like the estimated Glomerular Filtration Rate (eGFR), which measures how well the kidneys are filtering waste from the blood.

Participants in the study will be monitored for up to five years after their transplant. The study will also look at patient survival rates, the health of the transplanted kidney, and any side effects related to the imlifidase treatment. Additionally, the study will evaluate the patients' ability to participate in social activities and their overall quality of life. This information will help doctors understand the long-term benefits and risks of using imlifidase in kidney transplant patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, it is necessary to have signed the informed consent form. This confirms understanding of the trial and agreement to participate.

    Ensure willingness and ability to follow the trial protocol. This includes attending scheduled visits and following medical instructions.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying previous participation in the clinical trial 20-HmedIdeS-19 (PAES).

  3. Step 3

    Treatment with imlifidase

    The treatment involves the administration of imlifidase through an intravenous infusion. This is a method where the medication is delivered directly into the bloodstream through a vein.

    The specific dosage and frequency of administration will be determined by the medical team based on individual needs.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits will be scheduled to monitor health and the success of the kidney transplant.

    These visits will include assessments of graft failure-free survival, which means checking if the transplanted kidney is functioning well without failure.

    Additional evaluations will include checking kidney function through tests like estimated glomerular filtration rate (eGFR) and measuring serum/plasma creatinine levels.

  5. Step 5

    Long-term evaluation

    The trial aims to evaluate outcomes up to 5 years after the transplantation. This includes monitoring for any adverse events or complications related to the treatment.

    Patient survival and the survival of the transplanted kidney will be assessed over this period.

  6. Step 6

    Completion of the trial

    The trial is expected to conclude by December 31, 2028. At this point, a final assessment will be conducted to evaluate the overall success and safety of the treatment.

Who can join the trial?

5 criteria

  • Signed Informed Consent obtained before any trial-related procedures. This means you agree to participate in the study after being informed about it.
  • Willingness and ability to follow the study rules and procedures.
  • Previously received a kidney transplant in the clinical trial 20-HmedIdeS-19 (PAES).
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are eligible. This refers to groups who may need special protection or care.

Who cannot join the trial?

2 criteria

  • Patients who have already received a kidney transplant after being treated with Idefirix (imlifidase).
  • Patients who have received a kidney transplant that was a good match without needing Idefirix (imlifidase).
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Investigated drugs

Imlifidase is a medication used in this clinical trial to help patients who are highly sensitized and are undergoing kidney transplantation. It works by breaking down certain proteins in the immune system that can cause the body to reject a transplanted kidney. This medication is given to patients before they receive a kidney transplant to improve the chances of the transplant being successful. The trial aims to see how well patients do in the long term after receiving this treatment, focusing on whether the transplanted kidney continues to function without failure.

What is already known about the treatment

Idefirix (imlifidase) – Idefirix is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently used in medicine for patients who are highly sensitized and have undergone kidney transplantation, as well as for less sensitized patients with compatible kidney transplants. The main therapeutic use of Idefirix is to help these patients by reducing the risk of their bodies rejecting the new kidney. At the molecular level, Idefirix works by breaking down specific proteins called antibodies that can attack the transplanted kidney. It is classified pharmacologically as an enzyme that modifies the immune response.

Investigated diseases

Kidney Transplant Rejection – Kidney transplant rejection occurs when the recipient's immune system identifies the transplanted kidney as foreign and attacks it. This immune response can lead to inflammation and damage to the kidney tissue. Rejection can be acute, happening shortly after the transplant, or chronic, developing over a longer period. Symptoms may include decreased kidney function, increased blood pressure, and swelling. The progression of rejection can lead to a decline in kidney function and may eventually result in the loss of the transplanted kidney if not managed. Monitoring and managing immune responses are crucial to prevent or mitigate rejection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502727-21-00Protocol code20-HMedIdeS-20Estimated enrolment144 patientsSponsorHansa Biopharma AB

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