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Study on Human Normal Immunoglobulin to Prevent BKV Infection in Kidney Transplant Patients with Low Antibody Levels

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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 prevention of BKV infection in patients who have undergone a kidney transplant. The treatment being tested is called Privigen, which is a solution containing human normal immunoglobulin. This is a type of protein derived from blood that helps the body fight infections. The purpose of the study is to see if giving this treatment can reduce the occurrence of BKV infection in patients who have low levels of protective antibodies against the virus at the time of their transplant.

Participants in the study will receive the treatment through an intravenous injection, which means it will be administered directly into a vein. The study will monitor the patients over a period of time to see how well the treatment works in preventing the infection. The researchers will check the levels of the virus in the blood and urine at various points after the transplant, as well as monitor the patients' immune response to the virus.

The study will also look at other factors, such as the health of the transplanted kidney and the overall well-being of the patients over the course of a year. This includes checking for any side effects from the treatment and ensuring the patients' bodies are accepting the new kidney. The goal is to gather information that could help improve the care and outcomes for kidney transplant patients in the future.

The research process

The trial runs in 7 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, eligibility is confirmed. This includes being an adult kidney transplant recipient and understanding the study's purpose and risks.

    Written informed consent is required, and participants must be affiliated with a medical insurance scheme.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to measure BKV neutralizing antibody titers on the day of transplantation.

    This assessment helps determine the risk of BKV viremia, a condition where the virus is present in the blood.

  3. Step 3

    Medication administration

    The medication used in this study is Privigen 100 mg/ml solution for infusion, which is a human normal immunoglobulin.

    It is administered through an intravenous injection to help prevent BKV viremia.

  4. Step 4

    Follow-up assessments

    Follow-up assessments are scheduled at various intervals: day 10, day 31, day 52, month 3, month 6, and month 12 after transplantation.

    These assessments include measuring BKV viremia, BKV viruria (virus in urine), and other related health indicators.

  5. Step 5

    Primary endpoint evaluation

    The primary endpoint is the incidence of BKV viremia six months after transplantation.

    This evaluation helps determine the effectiveness of the preventive treatment.

  6. Step 6

    Secondary endpoint evaluation

    Secondary endpoints include various health measures such as BKV NAb titers, incidence of BKV nephropathy, and patient and graft survival at month 12.

    These evaluations provide additional insights into the patient's health and the treatment's impact.

  7. Step 7

    Study completion

    The study is estimated to end on August 21, 2026.

    Final assessments and evaluations are conducted to conclude the study and gather comprehensive data.

Who can join the trial?

4 criteria

  • Must be an adult, which means you need to be 18 years or older.
  • Must have received a kidney transplant. This includes those who have had more than one organ transplanted.
  • Must be able to understand the purpose and risks of the study. You need to be fully informed and have given your written consent to participate.
  • Must be part of a medical insurance scheme, meaning you have health insurance coverage.

Who cannot join the trial?

5 criteria

  • Patients who have had a kidney transplantation and are experiencing a BKV infection cannot participate. BKV is a virus that can affect the kidneys.
  • Patients with low levels of neutralizing antibodies against the donor's BKV strain at the time of transplantation are excluded. Neutralizing antibodies are proteins in the blood that help fight infections.
  • Patients with BKV viremia greater than 3 log10 copies/mL are excluded. BKV viremia means the presence of the BKV virus in the blood.
  • Both male and female patients are considered, but certain age ranges are specified for participation.
  • Patients who are part of a vulnerable population are not included. Vulnerable populations may include groups like children or the elderly who need special protection.
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Investigated drugs

Intravenous Immunoglobulins (IVIG) are used in this study to help prevent a viral infection called BKV viremia in patients who have received a kidney transplant. This medication is given through a vein and works by boosting the immune system. It is specifically used for patients who have low levels of certain antibodies that can fight off the BKV virus, which is a common concern after a kidney transplant. The goal is to reduce the chances of the virus becoming active and causing problems in the new kidney.

What is already known about the treatment

Intravenous Immunoglobulins (IVIG) – This medication is administered through an intravenous infusion, meaning it is given directly into a vein. Currently, IVIG is widely used in medicine and is well-documented in medical literature for various immune-related conditions. In this clinical trial, it is being investigated for its potential to prevent BKV viremia in kidney transplant recipients. The main therapeutic indication is to reduce the incidence of BKV infection in patients with low levels of neutralizing antibodies against the virus. IVIG works by providing a broad range of antibodies that can help neutralize pathogens and modulate the immune response. It is classified as an immunoglobulin therapy, which is used to support or modify the immune system.

Investigated diseases

  • Kidney Transplantation

    Kidney transplantation is a surgical procedure where a healthy kidney from a donor is placed into a person whose kidneys no longer function properly. The transplanted kidney takes over the work of filtering blood and producing urine. Over time, the body may attempt to reject the new kidney, which can lead to complications. Patients require lifelong monitoring and medication to prevent rejection and ensure the kidney functions well. The success of the transplant can be influenced by various factors, including the match between donor and recipient.

  • BKV Infection

    BKV infection is caused by the BK virus, which is a common virus that can remain dormant in the body. In individuals with weakened immune systems, such as those who have undergone kidney transplantation, the virus can reactivate. This reactivation can lead to BKV viremia, where the virus is present in the blood, and potentially progress to BKV nephropathy, affecting the kidney. The infection can cause damage to the transplanted kidney, leading to reduced function. Monitoring for BKV is crucial in transplant patients to manage and prevent complications.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515243-37-00Protocol code6997Estimated enrolment664 patientsSponsorLes Hopitaux Universitaires De Strasbourg

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