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Study on the Safety and Effectiveness of Tacrolimus and Drug Combination for Patients with BK Polyomavirus Infection After Kidney Transplantation

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 safety and effectiveness of different approaches to managing immunosuppressive therapy in patients who have undergone a kidney transplant and are experiencing a condition known as BK Polyomavirus DNAemia. This condition occurs when there is a significant amount of BK virus DNA in the blood, which can be a concern for kidney transplant recipients. The study will compare two groups: one group will continue their current immunosuppressive treatment, while the other group will have their treatment reduced according to standard guidelines. The goal is to see if maintaining the current level of immunosuppression is just as effective as reducing it in terms of how quickly the virus levels decrease in the blood.

The medications involved in this study include Tacrolimus, Azathioprine, Sirolimus, Belatacept, Mycophenolic Acid, Ciclosporin, Everolimus, Mycophenolate Mofetil, and Prednisolone. These medications are commonly used to suppress the immune system and prevent the body from rejecting a transplanted kidney. The study will monitor the time it takes for the virus levels to drop to a safe level, as well as other factors such as kidney function, any episodes of the body rejecting the kidney, and the presence of antibodies that might attack the transplanted organ.

Participants in the study will be randomly assigned to one of the two groups and will be monitored over a period of nine months. The study will track various health indicators, including kidney function and the presence of the virus in the blood, to determine the best approach to managing immunosuppression in these patients. The study aims to provide valuable information on how to best protect kidney transplant recipients from complications related to BK Polyomavirus while maintaining the health of the transplanted kidney.

The research process

The trial runs in 5 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 consent, indicating your understanding of the study's purpose and any potential risks involved. If you are between 7 and 18 years old, your legal guardian must also provide consent, and you must agree to participate.
For women of childbearing potential, a negative pregnancy test is required before starting the study. You must agree to use effective contraception or remain abstinent during the study period. Men must agree to use contraception or remain abstinent and refrain from donating sperm.
Step 2
Randomization
You will be randomly assigned to one of two groups: the experimental group or the control group. The experimental group will not reduce their immunosuppressive therapy, while the control group will follow standard care guidelines, which may involve reducing immunosuppressive therapy.
Step 3
Treatment phase
During the treatment phase, you will continue your current immunosuppressive medication regimen, which may include one or more of the following medications: tacrolimus, azathioprine, sirolimus, belatacept, mycophenolic acid, ciclosporin, everolimus, mycophenolate mofetil, and prednisolone. These medications are taken orally, except for belatacept, which is administered through an intravenous infusion.
The dosage and frequency of these medications will be determined by your healthcare provider and will be based on your specific needs and the study protocol.
Step 4
Monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted to evaluate your health and the effectiveness of the treatment. This includes measuring the level of BK Polyomavirus DNA in your blood and monitoring your kidney function.
The primary goal is to determine the time it takes for the BK Polyomavirus DNA levels to decrease to less than 1,000 IU/ml or to achieve a significant reduction. Secondary assessments will include changes in kidney function, occurrence of rejection episodes, and other health indicators.
Step 5
Completion of the study
The study will continue until the estimated end date in October 2032. Your participation may end earlier if the study objectives are met or if you choose to withdraw.
Upon completion, you will receive information about the study results and any relevant findings related to your health.

Who can join the trial?

8 criteria

Must have had a kidney transplant. This can also include transplants involving multiple organs.
Must have a condition called BKPyV-DNAemia with a level of 10,000 IU/ml or higher, and a specific type of immune cell called BKPyV-specific CD4 T cells at a level of 0.5 cells/µl or more.
For women who can have children: Must have a negative pregnancy test before starting the study and agree to avoid pregnancy by not having heterosexual intercourse or using a highly effective birth control method during the study.
For men: Must agree to avoid fathering a child by not having heterosexual intercourse or using birth control measures, and agree not to donate sperm during the study.
Must provide informed consent, which means understanding the purpose and risks of the study and agreeing to participate. For patients aged 7 to 18, both the patient and their legal guardian must agree to participate.
Must agree that if assigned to the experimental group, no changes to the study medication are allowed during participation.
Must currently be on an immunosuppression regime, which is a treatment to lower the body's immune response, with at least one or a combination of specific medications outlined in the study.
Must not have changed their immunosuppression treatment in the 4 weeks before joining the study.

Who cannot join the trial?

3 criteria

Patients who do not have BK Polyomavirus DNAemia after a kidney transplant cannot participate. This means that if you do not have a specific virus detected in your blood after receiving a kidney transplant, you cannot join the study.
Patients with a BK Polyomavirus DNAemia level less than 10,000 IU/ml cannot participate. This means that if the amount of the virus in your blood is below this level, you are not eligible.
Patients with BK Polyomavirus-specific CD4 T cells less than 0.5 cells/µl cannot participate. CD4 T cells are a type of white blood cell that helps your body fight infections. If you have fewer than this number, you cannot join the study.

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Verified sites

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Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Deutsches Herzzentrum Berlin
Berlin, Germany
Verified
Medizinische Hochschule Hannover
Hanover, Germany

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Investigated drugs

Immunosuppressive Therapy is a treatment used to lower the body's immune response. After a kidney transplant, the immune system might see the new kidney as a foreign object and try to attack it. This therapy helps prevent that by reducing the immune system's activity. In this clinical trial, the focus is on whether maintaining the current level of immunosuppressive therapy is as effective as reducing it when a specific virus, called BK Polyomavirus, is detected in the blood.

Tacrolimus

What is already known about the treatment

Immunosuppressive Therapy – This treatment is administered to patients who have undergone kidney transplantation and are experiencing BK Polyomavirus DNAemia, a condition where the virus is present in the blood. The current status of this therapy in medical literature is under investigation to determine if maintaining the current level of immunosuppression is as effective as reducing it, which is the standard practice. The main therapeutic indication is to manage BK Polyomavirus DNAemia in kidney transplant patients. At the molecular level, immunosuppressive therapy works by reducing the activity of the immune system to prevent it from attacking the transplanted organ. It is classified pharmacologically as an immunosuppressant.

Investigated diseases

BK Polyomavirus DNAemia after kidney transplantation – BK Polyomavirus DNAemia is a condition that occurs when the BK virus, a common virus that usually remains inactive in the body, becomes active and replicates in the blood. This condition is particularly significant in individuals who have undergone kidney transplantation, as their immune systems are suppressed to prevent organ rejection. The virus can cause damage to the transplanted kidney, leading to inflammation and potential impairment of kidney function. The progression of BK Polyomavirus DNAemia involves an increase in viral load in the blood, which can be detected through laboratory tests. If left unchecked, the virus can lead to complications such as nephropathy, which is a disease of the kidney. Monitoring and managing the viral load is crucial to prevent damage to the transplanted organ.