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Study of belatacept, tacrolimus and ciclosporin in heart transplant patients at risk of kidney failure

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 study focuses on patients who have undergone heart transplantation and are at risk of developing chronic kidney failure. The research examines the effectiveness of belatacept, a medication given through intravenous infusion, as an alternative treatment that may be less harmful to the kidneys compared to standard medications. The other medications used in the study include tacrolimus, which comes as capsules under the brand names Advagraf and Prograf, and ciclosporin (Neoral) soft capsules.

The purpose of this research is to determine if belatacept can help improve kidney function in heart transplant patients when used together with gradually reduced doses of traditional anti-rejection medications. The study will last for 12 months after heart transplantation, during which patients will receive monthly infusions of belatacept.

During the study, patients will have their kidney function monitored through blood tests. The research team will also perform myocardial biopsies (heart tissue samples) and check for signs of organ rejection. Additionally, patients will be monitored for blood sugar levels and other health indicators to ensure their safety throughout the treatment period.

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

    Initial assessment at 3 months post-transplant

    Your participation begins 3 months after heart transplantation

    Medical team will evaluate your kidney function by measuring creatinine levels

    Blood tests will be performed to check for anti-HLA antibodies

    Initial fasting blood glucose and HbA1c (blood sugar control) measurements will be taken

  2. Step 2

    Treatment initiation

    You will begin receiving belatacept through intravenous infusion (NULOJIX 250 mg)

    Your current medication with calcineurin inhibitors (Advagraf, Prograf, or Neoral) will be gradually reduced

    Monthly infusions of belatacept will continue for 9 months

  3. Step 3

    Monthly monitoring

    Regular heart muscle biopsies will be performed to monitor organ health

    Blood tests will check for presence of antibodies

    Your kidney function will be regularly monitored

    Any need for dialysis sessions will be recorded

  4. Step 4

    12-month evaluation

    Final assessment of your kidney function through creatinine measurement

    Final blood sugar control tests (fasting glucose and HbA1c)

    Final antibody testing

    Evaluation of treatment effectiveness by comparing kidney function between 3 and 12 months

  5. Step 5

    Follow-up period

    If you are of childbearing age, continue using effective contraception for 6 weeks after study completion

    Medical team will continue monitoring your health status

Who can join the trial?

9 criteria

  • Must be a heart transplant recipient for at least 3 months
  • Must be 18 years or older
  • Must not have donor-specific antibodies (proteins that can attack the transplanted heart) at the start of the study
  • Must have either: - Kidney function test showing filtration rate less than 30ml/min, or - A decrease in kidney function of more than 50% between heart transplant and 3 months after, stable for 15 days
  • Must have positive Epstein-Barr virus (EBV) blood test results
  • Must sign an informed consent form after receiving information about the study
  • For women who can become pregnant: - Must have a negative pregnancy test - Must agree to use effective birth control during the study and for 6 weeks after
  • Must be able to understand and communicate clearly with the study team
  • Must have active social security coverage

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years
  • Active hepatitis B (liver infection) or positive test for hepatitis B surface antigen
  • Active hepatitis C infection
  • Active tuberculosis infection
  • Severe kidney dysfunction requiring dialysis
  • History of organ transplant other than heart
  • Pregnant or breastfeeding women
  • Known allergic reactions to transplant medications
  • Active cancer or history of cancer in the past 5 years
  • Severe infections requiring hospitalization
  • Participation in other clinical trials within the past 30 days
  • Inability to provide informed consent
  • History of substance abuse within the past year
  • Serious heart rhythm problems not controlled by medication
  • Severe lung disease requiring oxygen therapy
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Investigated drugs

  • Belatacept

    is a medication given by infusion that helps prevent organ rejection after transplantation. It works by suppressing the immune system in a way that is less harmful to the kidneys compared to traditional anti-rejection medications. This medication is particularly beneficial for transplant patients who are at risk of developing kidney problems.

  • Calcineurin inhibitors

    are traditional anti-rejection medications that help prevent organ rejection after transplantation. While effective at preventing rejection, they can sometimes cause kidney problems over time. In this trial, these medications are gradually reduced while belatacept is administered.

What is already known about the treatment

Belatacept - A biological immunosuppressive medication administered through intravenous infusion, specifically designed to prevent organ rejection in transplant patients. This selective T-cell costimulation blocker works by binding to CD80 and CD86 proteins on antigen-presenting cells, thereby inhibiting T-cell activation and reducing the risk of organ rejection. Currently approved for use in kidney transplantation, it is being investigated for heart transplant patients as a less nephrotoxic alternative to traditional calcineurin inhibitors, particularly beneficial for patients at risk of chronic kidney disease. The medication represents an innovative approach in transplant medicine due to its targeted mechanism of action and potentially improved renal safety profile compared to conventional immunosuppressants.

Investigated diseases

Early Graft Dysfunction - A condition that occurs shortly after heart transplantation where the newly transplanted heart doesn't function properly. The condition typically develops within the first few hours to days after transplantation. It involves decreased heart pumping capacity and can affect how well the heart supplies blood to the body. The dysfunction may show itself through various signs of poor heart performance. Early graft dysfunction can affect both the right and left sides of the transplanted heart. The condition can vary in severity from mild to severe. Chronic Kidney Disease (CKD) - A gradual loss of kidney function that develops over time. The kidneys become less efficient at filtering waste products from the blood. The condition progresses through several stages, with kidney function gradually declining. CKD can cause fluid retention, changes in blood pressure, and alterations in the body's chemical balance. The disease often develops slowly over months or years. Note: These two conditions are mentioned or implied in the trial data through the objectives and endpoints.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516541-40-00Protocol codeRC19_0133Estimated enrolment25 patientsSponsorCentre Hospitalier Universitaire De Nantes

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