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Study of Imlifidase for Patients Undergoing Kidney Transplant from a Living Donor

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 studying the treatment of patients who are undergoing a kidney transplant from a living donor. The treatment being tested is called Imlifidase, which is given as a solution through an infusion. The main goal of the study is to see if Imlifidase can help patients who are highly sensitized, meaning they have a strong immune response, to achieve a negative virtual crossmatch. A virtual crossmatch is a test that predicts if the patient's immune system will accept the donor kidney.

Participants in the study will receive Imlifidase treatment, and the researchers will observe how well it works in converting a positive virtual crossmatch to negative within six hours. The study will also look at other factors, such as the need for a second dose of Imlifidase, changes in specific antibodies that might affect the transplant, and the overall function of the transplanted kidney over time. The safety of Imlifidase will be monitored by checking for any reactions to the infusion and other potential side effects.

The study will follow participants for up to one year after the transplant to evaluate the survival of both the patient and the transplanted kidney. Researchers will also assess the occurrence of any rejection episodes and monitor the kidney's function through various tests. The study aims to provide valuable information on the effectiveness and safety of Imlifidase in improving outcomes for patients receiving a kidney transplant from a living donor.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate and understand the study requirements.
You must meet specific criteria, such as being a highly sensitized kidney transplant candidate between 18 and 65 years old, and have a low probability of receiving a transplant through a kidney exchange program.
Step 2
Pre-treatment assessment
Before receiving any treatment, a series of tests will be conducted to ensure you meet all necessary health criteria. This includes checking for donor-specific antibodies and ensuring compatibility with the donor.
Step 3
Imlifidase treatment
You will receive a medication called imlifidase as a solution for infusion. This treatment aims to help achieve a negative crossmatch, which is important for the success of the kidney transplant.
The treatment may involve up to two doses, and the primary goal is to convert a positive crossmatch to negative within 6 hours after administration.
Step 4
Monitoring after treatment
After receiving imlifidase, your health will be closely monitored. This includes checking for any infusion-related reactions within 48 hours and evaluating the need for a second dose.
Your antibody levels will be assessed daily until 14 days after treatment to monitor any changes.
Step 5
Post-transplant follow-up
Following the kidney transplant, your renal function will be evaluated at various intervals, including 24 hours, 2 weeks, and at 1, 3, 6 months, and 1 year.
The study will also assess your overall health, including any adverse events or infections, up to 12 months after the transplant.
Step 6
Long-term evaluation
The study will continue to evaluate the safety and effectiveness of imlifidase treatment over a longer period, including patient and graft survival at 12 months.
Your participation will help gather important data on the incidence of acute rejection and other potential outcomes.

Who can join the trial?

8 criteria

Must be a **highly sensitized** kidney transplant candidate. This means your body has a strong immune response to most donor kidneys. The test used to measure this is called **cPRA**, and it must be **50% or higher**.
Must be between **18 and 65 years old**.
Must have a **low chance** of getting a transplant through a kidney exchange program from a living donor.
Must be part of a **living donor program** and have an accepted potential living donor.
Both the donor and recipient must meet the eligibility criteria for donation and kidney transplantation according to national guidelines.
Must have a **donor-specific antibody** (DSA) or a positive crossmatch with a non-HLA identical donor. This means your body reacts to specific proteins from the donor's kidney. The DSA must have a **MFI** (mean fluorescence intensity) greater than **3,000** but less than **10,000** in diluted serum samples. You can have a maximum of two Class II DSAs and a maximum of 17 points in the **Jordan RIS Score**.
Women who can have children must use **contraceptive measures** because the treatment is not recommended during pregnancy.
Must have given **written informed consent**, which means you have signed and dated a document agreeing to participate and understand the study requirements.

Who cannot join the trial?

2 criteria

Patients who have had a **kidney transplant** before cannot participate.
Patients who are not able to achieve a **negative virtual crossmatch** with the treatment cannot participate. A negative virtual crossmatch means that the patient's body is less likely to reject the new kidney.

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Verified sites

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Hospital Clinic De Barcelona
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Barcelona, Spain

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Investigated drugs

Imlifidase is a medication used in this clinical trial to help patients who are receiving a kidney from a living donor. The main goal of using Imlifidase is to make sure that the patient's body does not reject the new kidney. It works by breaking down certain proteins in the immune system that can cause the body to attack the transplanted kidney. This helps in achieving a negative virtual crossmatch, which means that the patient's immune system is less likely to react negatively to the donor kidney. This treatment is especially important for patients who are highly sensitized, meaning they have a higher risk of rejecting the transplant. By using Imlifidase, doctors hope to improve the chances of a successful kidney transplant for these patients.

Imlifidase

What is already known about the treatment

Imlifidase – Imlifidase is administered through an injection, typically given by a healthcare professional. It is currently being studied in clinical trials for its use in kidney transplantation, specifically for patients who are highly sensitized and have a living donor. The main therapeutic indication for Imlifidase is to help these patients achieve a negative virtual crossmatch, which is crucial for successful transplantation. At the molecular level, Imlifidase works by breaking down antibodies that can cause rejection of the transplanted kidney. It is classified pharmacologically as an enzyme that targets and cleaves specific proteins in the immune system.

Investigated diseases

Kidney Transplant – A kidney transplant is a surgical procedure to place a healthy kidney from a donor into a person whose kidneys no longer function properly. The disease progression involves the gradual decline of kidney function, leading to end-stage renal disease, where the kidneys can no longer filter waste and excess fluids from the blood. This condition requires either dialysis or a kidney transplant to sustain life. After transplantation, the body may recognize the new kidney as foreign and attempt to reject it, which can lead to complications. The immune system's response to the new organ is a critical factor in the progression and success of the transplant. Regular monitoring and management are essential to ensure the transplanted kidney functions well over time.