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Study on Preventing Rejection in Kidney Transplant Patients Using Rabbit Anti-Human Thymocyte Immunoglobulin and Basiliximab

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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 patients who have undergone a kidney transplant. The study is comparing two treatments to see which one is more effective in preventing a specific type of rejection that can occur after a transplant. The first treatment being studied is called Thymoglobuline, which contains a substance known as rabbit anti-human thymocyte immunoglobulin. This is a type of medication that helps to reduce the activity of the immune system. The second treatment is called Simulect, which contains basiliximab, another medication that also helps to control the immune system's response.

The purpose of the study is to determine if Thymoglobuline is more effective than Simulect in preventing acute rejection of the transplanted kidney during the first year after the transplant. Participants in the study will receive one of these treatments and will be monitored over time to see how well the treatment works in preventing rejection. The study will also look at other factors, such as the overall health of the kidney and any side effects that may occur.

Throughout the study, participants will receive regular check-ups and tests to monitor their health and the function of their transplanted kidney. The study aims to provide valuable information that could help improve the care and outcomes for future kidney transplant patients. The trial is expected to continue for several years to gather comprehensive data on the effectiveness and safety of these treatments.

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, participants will be informed about the trial's objectives and procedures. Written informed consent is required to confirm understanding and agreement to participate.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes checking age, specific antibody levels, and other health criteria.

  3. Step 3

    Randomization

    Participants will be randomly assigned to one of two groups: one receiving rabbit anti-human thymocyte immunoglobulin (rATG) and the other receiving basiliximab.

  4. Step 4

    Treatment administration

    Participants in the rATG group will receive Thymoglobuline as an infusion. Participants in the basiliximab group will receive Simulect as an infusion or injection. The specific dosage and frequency will be determined by the study protocol.

  5. Step 5

    Post-transplantation monitoring

    Participants will be monitored for the incidence of biopsy-proven acute rejection (BPAR) during the first year after transplantation. Regular check-ups and tests will be conducted to assess health and treatment effectiveness.

  6. Step 6

    Follow-up assessments

    Follow-up assessments will occur at various intervals, including day 10, month 1, month 3, month 6, year 1, year 2, and year 3. These assessments will include tests to measure kidney function and check for any new antibodies.

  7. Step 7

    Long-term evaluation

    Participants will be evaluated for long-term outcomes, including the incidence of BPAR, death, and graft loss at year 3. Additional health and economic evaluations will be conducted to assess the overall impact of the treatments.

Who can join the trial?

6 criteria

  • Patients aged between 18 and 79 years old
  • At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI (Mean Fluorescence Intensity) greater than or equal to 2000
  • Graft incompatibility rate (TGI) less than 85%
  • Ability to understand the nature and objectives of the study and to comply with its requirements
  • Written informed consent obtained from the participant
  • Participants must be covered by or entitled to social security

Who cannot join the trial?

6 criteria

  • Patients who have had a kidney transplant cannot participate. A kidney transplant is a surgery to place a healthy kidney from a donor into a person whose kidneys no longer function properly.
  • Patients with pre-existing DSAs are excluded. DSAs, or donor-specific antibodies, are proteins made by the immune system that can attack a transplanted organ.
  • Patients who are not in the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not part of the specified clinical trial group are excluded. This means only certain groups of people are being studied.
  • Both male and female patients can participate, but they must meet all other criteria.
  • Patients who are considered part of a vulnerable population are not included. Vulnerable populations are groups of people who may need special protection or care.
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Investigated drugs

  • rATG

    is a medication used in this clinical trial to help prevent the body from rejecting a new kidney after a transplant. It works by reducing the activity of the immune system, which is the body's defense system that can sometimes attack the new kidney as if it were a harmful invader. By calming down the immune system, rATG helps the body accept the new kidney more easily.

  • Basiliximab

    is another medication used in the trial to prevent the body from rejecting a transplanted kidney. It works by blocking certain signals in the immune system that can lead to rejection. This helps the body accept the new kidney and reduces the risk of complications after the transplant. Basiliximab is often used in combination with other medications to provide a more comprehensive approach to preventing rejection.

What is already known about the treatment

  • Basiliximab

    Basiliximab is administered through an intravenous infusion, which means it is given directly into a vein. It is currently used in medicine to help prevent the body from rejecting a transplanted kidney. The main therapeutic indication for basiliximab is to prevent acute rejection in kidney transplant recipients. At the molecular level, basiliximab works by blocking a specific protein on the surface of immune cells, which helps to reduce the immune response against the transplanted organ. It is classified as an immunosuppressant medication.

  • Rabbit Anti-Thymocyte Globulin (rATG)

    Rabbit Anti-Thymocyte Globulin, or rATG, is also administered through an intravenous infusion. It is used in medical practice to prevent the body from rejecting a transplanted kidney, particularly in patients who are at higher risk of rejection. The main therapeutic indication for rATG is to prevent acute rejection in kidney transplant recipients. At the molecular level, rATG works by depleting certain immune cells that are responsible for attacking the transplanted organ. It is classified as an immunosuppressant medication.

Investigated diseases

Kidney Transplant Rejection – Kidney transplant rejection occurs when the recipient's immune system attacks the transplanted kidney, viewing it as a foreign object. This process can be acute or chronic, with acute rejection happening within the first few months post-transplant and chronic rejection developing over a longer period. Acute rejection is characterized by a sudden decline in kidney function, often accompanied by symptoms such as fever, pain over the transplant site, and reduced urine output. Chronic rejection progresses more slowly and may lead to gradual loss of kidney function. The immune response involves both cellular and antibody-mediated mechanisms, which can damage the kidney tissue. Monitoring and managing immune responses are crucial to prevent rejection and maintain kidney function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502007-30-00Estimated enrolment244 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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