RecruitingRare disease

Study on Imlifidase and Drug Combination for Kidney Transplant in Highly Sensitized Children

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 helping children who are highly sensitive and need a kidney transplant. These children have a condition where their immune system reacts strongly against a potential kidney donor, making it difficult to find a suitable match. The study is testing a treatment called imlifidase, which aims to reduce this immune reaction, allowing the child to receive a kidney from a donor they previously could not. The main goal is to see if imlifidase can change a positive crossmatch test, which indicates a strong immune reaction, to a negative one, meaning the child can safely receive the kidney.

During the study, children will receive imlifidase through an intravenous infusion, which means the medicine is given directly into a vein. The study will also involve other medications like methylprednisolone, a type of corticosteroid that helps reduce inflammation, and rituximab, which is used to lower certain immune responses. The trial will monitor the children's health and kidney function for up to five years after the transplant to ensure the treatment is safe and effective. This includes checking how well the new kidney is working and looking for any side effects or complications.

The study will also use a placebo, which is a substance with no active medication, to compare the effects of the treatment. The trial aims to provide valuable information on how well imlifidase works in helping children receive a kidney transplant and improve their quality of life. By participating in this study, researchers hope to find a way to make kidney transplants possible for children who are highly sensitive and have limited options for donors.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will have already provided a signed informed consent. This consent is necessary for you to participate in the study and confirms your understanding of the trial procedures.
Step 2
Initial assessment
You will undergo an initial assessment to confirm your eligibility. This includes verifying that you are a highly sensitised patient with a positive crossmatch against a donor kidney and that you meet other criteria such as age and health status.
Step 3
Imlifidase treatment
You will receive an intravenous infusion of imlifidase. This treatment aims to convert your positive crossmatch test to negative, making it possible for you to receive a kidney transplant. The conversion is expected to occur within 24 hours after the start of the treatment.
Step 4
Monitoring after imlifidase
Your health and response to the imlifidase treatment will be closely monitored. This includes checking for any infusion-related reactions within 48 hours and assessing your kidney function and other health parameters over time.
Step 5
Kidney transplant
Once your crossmatch test is negative, you will proceed to receive a kidney transplant from a living or deceased donor. The timing of the transplant will depend on donor availability and your health status.
Step 6
Post-transplant follow-up
After the transplant, you will have regular follow-up visits to monitor your kidney function and overall health. This includes measuring your estimated glomerular filtration rate (eGFR), serum creatinine, and other markers up to 5 years after the transplant.
Step 7
Long-term monitoring
Your health will be monitored for up to 5 years to assess the success of the transplant and any potential complications. This includes checking for graft survival, dialysis dependency, and any adverse events or infections.

Who can join the trial?

8 criteria

Signed Informed Consent must be obtained from the patient, parent, legal guardian, or an independent witness, depending on the patient's age, before any trial-related procedures.
The patient must be highly sensitised, meaning they have a high level of antibodies in their blood that react to foreign tissue, with a panel reactive antibodies (PRA) level of 80% or higher.
The patient can be male or female and must be between the ages of 1 to 17 years (up to the day before their 18th birthday) at the time of screening.
The patient must have end-stage renal disease (ESRD), which means their kidneys are no longer working well enough to live without dialysis or a transplant, and they must be waiting for a kidney transplant from a living or deceased donor.
The patient must be considered transplantable, meaning they are suitable for a transplant, including being the right size for the donor kidney, at the time of giving informed consent for trial participation.
The patient must have previously tried and not succeeded with desensitisation treatments like plasmapheresis, IVIg, or anti-CD20, or have an anti-HLA antibody status that is considered too difficult for successful desensitisation, based on the physician's experience with similar patients.
The patient must have a positive crossmatch test, which means their blood reacts to the donor's blood, determined by FCXM and/or CDCXM tests. For deceased donor patients, if physical crossmatch tests are not possible due to time constraints, patients may be included based on a virtual crossmatch (vXM) that predicts a positive crossmatch test.
The patient must show willingness and ability to comply with the study protocol, as judged by the investigator.

Who cannot join the trial?

5 criteria

Patients who are not highly sensitized, meaning their immune system is not overly reactive to a donor kidney.
Patients who do not have a positive crossmatch, which is a test showing that their immune system would attack the donor kidney.
Patients who are not in the pediatric age range, meaning they are not children.
Patients who are not part of the specific clinical trial group being studied.
Patients who are not considered part of a vulnerable population, which means they do not have special needs or circumstances that require extra protection.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Helsinki University Central Hospital
Verified
Helsinki, Finland
Hospital Sant Joan De Deu Barcelona
Verified
Esplugues De Llobregat, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

Imlifidase is a medication used in this clinical trial to help children who need a kidney transplant. It works by breaking down certain proteins in the immune system that can cause the body to reject a new kidney. In this trial, imlifidase is given to children who have a high risk of rejecting a kidney from a donor. The goal is to change their immune response so that their body can accept the new kidney more easily. This is done by converting a positive crossmatch, which indicates a likely rejection, to a negative one, meaning the body is less likely to reject the transplant after treatment with imlifidase.

What is already known about the treatment

Imlifidase – Imlifidase is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its effectiveness and safety in helping highly sensitized pediatric patients, aged 1 to 17, who are awaiting a kidney transplant and have a positive crossmatch against a donor. The main therapeutic use of imlifidase is to convert a positive crossmatch to negative, allowing for successful kidney transplantation. At the molecular level, imlifidase works by breaking down specific antibodies that are responsible for the positive crossmatch, thus reducing the immune response against the donor kidney. It is classified pharmacologically as an enzyme that targets and cleaves immunoglobulin G (IgG) antibodies.

Investigated diseases

Highly Sensitized Pediatric Patients with a Positive Crossmatch Against a Living or Deceased Donor Kidney – This condition involves children who have developed a strong immune response against potential kidney donors, making it difficult to find a compatible match for transplantation. The immune system of these patients has been sensitized, often due to previous transplants, blood transfusions, or pregnancies, leading to the production of antibodies that attack donor tissues. When a crossmatch test is positive, it indicates that the recipient's antibodies will likely attack the donor kidney, causing rejection. The progression of this condition involves ongoing sensitization, which can increase over time, further complicating the search for a suitable donor. The presence of these antibodies can lead to immediate rejection of the transplanted organ if not addressed. Managing this condition requires careful monitoring and strategies to reduce antibody levels to improve the chances of a successful transplant.