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Study on Switching from Tacrolimus or Ciclosporin to Belatacept for Adolescents with Kidney Transplants

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 treatments for adolescents who have received a kidney transplant, also known as a renal allograft. The study involves two different types of medications used to prevent the body from rejecting the transplanted kidney. One group of participants will continue using a type of medication called calcineurin inhibitors, which includes drugs like tacrolimus and ciclosporin. The other group will switch to a medication called belatacept, which is given through an infusion into a vein. Belatacept is also known by its code name LEA29Y or BMS224818.

The purpose of the study is to evaluate the benefits and risks of switching from calcineurin inhibitors to belatacept in these young patients. The study will observe how well the kidney transplant continues to function and how well the patients adhere to their medication schedules. Participants will be randomly assigned to either continue their current medication or switch to belatacept. The study will last for 24 months, during which time the health of the kidney transplant and the overall well-being of the participants will be monitored.

This study is important for understanding whether switching to belatacept can provide better outcomes for adolescent kidney transplant recipients compared to continuing with calcineurin inhibitors. The findings could help improve treatment strategies and long-term health for young people who have undergone kidney transplants.

The research process

The trial runs in 5 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 are randomly assigned to one of two groups. One group will continue their current medication, while the other group will switch to a new medication regimen.

  2. Step 2

    Medication regimen

    Participants continuing their current treatment will keep taking tacrolimus or ciclosporin orally. The exact dosage and frequency will be based on the participant's current prescription.

    Participants switching to the new regimen will receive belatacept through an intravenous infusion. The healthcare team will provide specific instructions on the dosage and frequency.

  3. Step 3

    Regular check-ups

    Participants will attend regular check-ups to monitor their health and the function of their kidney transplant. These check-ups will include blood tests and other assessments as needed.

  4. Step 4

    Monitoring and feedback

    Throughout the study, participants will be asked to provide feedback on their health and any side effects experienced. This information is crucial for evaluating the safety and effectiveness of the treatment.

  5. Step 5

    End of study

    The study will conclude 24 months after the participant's randomization. At this point, the final assessments will be conducted to evaluate the outcomes of the treatment.

Who can join the trial?

4 criteria

  • Must be a male or female between the ages of 12 and less than 18 years old.
  • Must have documented EBV seropositivity before the transplant and randomization.
    (This means you have been tested and found to have antibodies against the Epstein-Barr Virus, which shows past infection.)
  • Must be receiving a stable medication regimen that includes a CNI (calcineurin inhibitor) and mycophenolate, with or without corticosteroids, for more than 1 month before randomization.
    (This means your current medication plan has not changed recently and includes specific drugs to help prevent organ rejection.)
  • Must have stable kidney function for 12 weeks before screening, as assessed by the study doctor and based on specific criteria for eGFR and proteinuria.
    (This means your kidney function has been consistent and meets certain medical standards.)

Who cannot join the trial?

5 criteria

  • Patients who have not had a kidney transplant at least 6 months ago cannot participate.
  • Patients who are not adolescents (typically ages 10-19) cannot participate.
  • Patients who are not currently taking a medication called **CNI** (Calcineurin Inhibitor) cannot participate. This is a type of drug that helps prevent the body from rejecting a transplanted organ.
  • Patients who are unable to switch to a medication called **belatacept** cannot participate. Belatacept is a drug used to help prevent organ rejection after a kidney transplant.
  • Patients who are not willing to follow the study procedures and requirements cannot participate.
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Investigated drugs

  • Belatacept

    is a medication used to help prevent the body from rejecting a transplanted kidney. It works by weakening the immune system so that it does not attack the new kidney. In this trial, belatacept is being tested to see if it can be a better option for young people who have had a kidney transplant, compared to other medications they might be taking.

  • Calcineurin Inhibitors

    are a group of medications that are commonly used to prevent organ rejection in people who have received a transplant. They work by suppressing the immune system to stop it from attacking the transplanted organ. In this study, the effects of continuing with calcineurin inhibitors are being compared to switching to belatacept to see which is more effective for young kidney transplant recipients.

What is already known about the treatment

Belatacept – Belatacept is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials for its use in adolescent patients who have received a kidney transplant, specifically to see if it can replace other medications that suppress the immune system. The main use of Belatacept is to prevent the body from rejecting a transplanted kidney. It works by blocking a specific signal that is needed for the immune system to attack the transplanted organ. Belatacept is classified as an immunosuppressant, which means it helps to lower the activity of the immune system to prevent organ rejection.

Investigated diseases

Adolescent Renal Allografts – Adolescent renal allografts refer to kidney transplants received by individuals in their teenage years. After transplantation, the body may recognize the new kidney as foreign, potentially leading to immune responses. Over time, the transplanted kidney may experience changes in function, which can be monitored through measures like estimated glomerular filtration rate (eGFR). The progression of the condition involves maintaining the health and function of the transplanted kidney while managing the body's immune response. The focus is on ensuring the kidney continues to function properly and supports the body's needs. Regular monitoring and adjustments in care are essential to support the long-term health of the transplant.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501677-39-00Protocol codeIM103402Estimated enrolment109 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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