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Study on Preventing BK Virus Infection in Kidney Transplant Patients Using Mycophenolic Acid, Mycophenolate Mofetil, and Sirolimus

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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 preventing viral infections caused by the BK virus after a kidney transplant. The study is examining how the body's immune system, which is responsible for fighting infections, can be strengthened to protect against this virus. The trial involves patients who have received a kidney transplant and are on specific medications to suppress their immune system, which is necessary to prevent the body from rejecting the new kidney. These medications include tacrolimus, mycophenolate mofetil (also known as CellCept), mycophenolic acid (also known as Myfortic), and sirolimus (also known as Rapamune).

The purpose of the study is to understand how different combinations of these medications affect the immune system's ability to fight the BK virus. Participants will be monitored for changes in their immune response and viral load, which is the amount of virus present in the blood. The study will also look at how the immune system's cells, such as T cells and B cells, respond to the virus. This includes examining specific proteins and antibodies that play a role in fighting infections.

Participants in the study will take their prescribed medications and have regular check-ups to monitor their health and immune response. The study will last for up to 16 weeks, during which time researchers will collect and analyze data to better understand how to prevent BK virus infections in kidney transplant patients. The findings from this study could help improve treatment strategies and outcomes for future patients undergoing kidney transplants.

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 study

    Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the role of the body's immune response against the BK virus after a kidney transplant.

    The patient will be required to provide written consent, confirming their understanding and willingness to participate in the study.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes being at least 18 years old, having received a kidney transplant, and having a detectable viral load of the BK virus in the blood.

    The patient's kidney function and protein levels in urine will be evaluated to ensure they meet the study's criteria.

  3. Step 3

    Medication regimen

    The patient will continue their maintenance immunosuppressive regimen, which may include medications such as tacrolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPS), sirolimus (rapamycin), and corticosteroids.

    These medications are taken orally in various forms such as capsules or tablets, with specific dosages and frequencies as prescribed by the healthcare provider.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient's immune response to the BK virus will be monitored through regular blood tests and assessments.

    The study aims to observe changes in the immune response and viral load in the blood over time.

  5. Step 5

    Evaluation of immune response

    The study will evaluate the patient's immune response at different biological levels, focusing on specific immune cells and antibodies that target the BK virus.

    Advanced techniques will be used to analyze the patient's immune cells and their ability to respond to the virus.

  6. Step 6

    Completion of the study

    The study is expected to conclude by April 30, 2025, at which point the patient's participation will end.

    The results of the study will contribute to understanding how different immunosuppressive regimens affect the immune response to the BK virus after kidney transplantation.

Who can join the trial?

9 criteria

  • The patient must be at least 18 years old.
  • The patient must be able to give informed consent in writing. This means they understand the study and agree to participate.
  • The patient must be receiving a kidney transplant.
  • The patient must have a maintenance immunosuppressive regimen based on one of the following combinations:
    • Tacrolimus + MMF/MPS + corticosteroids
    • Tacrolimus + rapamycin + corticosteroids
    • The patient must have a viral load detectable by PCR in their blood against the BK-virus. This means the virus is present in their blood and can be measured.
    • The patient must have had a kidney transplant within the last 12 months before the viral load was detected.
    • The patient must have stable kidney function with an estimated glomerular filtration rate (eGFR) of at least 35 ml/min/1.73 m². eGFR is a measure of how well the kidneys are working.
    • The patient must have a urine protein/creatinine ratio value of less than 1 g/g. This is a test to check for protein in the urine, which can indicate kidney health.

Who cannot join the trial?

10 criteria

  • Patients who have had a kidney transplant less than 3 months ago.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe allergic reactions to medications.
  • Patients with active infections that require treatment.
  • Patients with a history of cancer within the last 5 years, except for skin cancer that is not melanoma.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe liver disease.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who are unable to follow the study procedures or attend study visits.
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Investigated drugs

mTor-i drugs are a type of medication used to help prevent the body from rejecting a transplanted kidney. These drugs work by blocking a specific pathway in the immune system, which helps to reduce the activity of immune cells that might attack the new kidney. By doing this, mTor-i drugs help to protect the transplanted organ and improve its chances of functioning well in the body.

What is already known about the treatment

BK-VAX – This medication is administered as a vaccine to help prevent viral infections caused by the BK polyomavirus, particularly after a kidney transplant. Currently, it is being studied in clinical trials to understand its effectiveness in boosting the body's immune response against the virus, especially when different immunosuppressive drugs are used. The main therapeutic goal is to prevent BK virus infections, which can be a significant complication after kidney transplantation. The vaccine works by enhancing the body's adaptive immunity, which is the part of the immune system that learns to recognize and fight specific viruses. It is classified as an immunological agent, focusing on strengthening the immune system's ability to combat viral infections.

Investigated diseases

BK Virus Infection – BK Virus Infection is a condition caused by the BK polyomavirus, which primarily affects individuals with weakened immune systems, such as those who have undergone kidney transplantation. The virus can remain dormant in the body and become active when the immune system is suppressed. Once active, it can lead to inflammation and damage in the kidneys, potentially affecting kidney function. The infection progresses by increasing the viral load in the blood, which can be monitored to assess the severity of the infection. The immune response to the virus involves various immune cells, including T cells and B cells, which may produce specific antibodies to combat the virus. The progression of the infection can vary depending on the individual's immune response and the immunosuppressive treatments they are receiving.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504309-35-00Protocol codeBK-VAXEstimated enrolment70 patientsSponsorFir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

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