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Study of Belatacept versus Tacrolimus in Kidney Transplant Recipients with Subclinical Antibody Mediated Rejection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients who have undergone kidney transplantation and are experiencing a specific condition called subclinical antibody mediated rejection. This type of rejection occurs when the body produces antibodies against the transplanted kidney, even though there may not be obvious signs of the kidney not working properly. The study specifically looks at cases where these antibodies, called donor specific antibodies, develop after the transplant.

The study compares two different medications used to prevent rejection of the transplanted kidney. The first medication is belatacept, which is given through an intravenous injection, combined with standard treatment. The second medication is tacrolimus, which is taken as oral capsules, also combined with standard treatment. The purpose is to determine which medication works better in treating rejection when these new antibodies are detected.

The treatment period lasts for 12 months, during which patients will receive either belatacept or tacrolimus. Throughout the study, doctors will monitor how well the kidney is working by checking kidney function through blood tests and examining small samples of kidney tissue. They will also track the levels of antibodies in the blood and watch for any side effects of the medications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial biopsy and diagnosis

    A biopsy of your transplanted kidney will be performed to check for signs of rejection

    The biopsy results will determine if you have subclinical antibody mediated rejection (sABMR), which means your body may be developing antibodies against your transplanted kidney without obvious symptoms

  2. Step 2

    Treatment assignment

    Based on your biopsy results, you will receive one of two medication combinations:

    Option 1: Belatacept (Nulojix) given by intravenous injection, combined with standard care medications

    Option 2: Tacrolimus (Advagraf) taken as oral capsules, combined with standard care medications

  3. Step 3

    12-month follow-up period

    Regular monitoring of your kidney function through blood and urine tests

    Doctors will check your creatinine levels and calculate how well your kidney is filtering (eGFR)

    Your urine will be tested for protein levels

    Blood tests will check for viral infections (BK virus, CMV, and EBV)

    After 12 months, another kidney biopsy will be performed to check your kidney's condition

  4. Step 4

    Extended monitoring

    Your kidney function will continue to be monitored up to 36 months

    Regular blood and urine tests will continue

    Your medical records will be reviewed to track any complications or hospitalizations

    The presence of antibodies against your transplanted kidney will be monitored through blood tests

Who can join the trial?

6 criteria

  • Must be a person who has received a kidney transplant
  • Must be an adult (18 years or older)
  • Must have developed new antibodies against the donor kidney (de novo DSA) that: - Were not present on the day of transplantation - Were not present in blood tests before transplantation - Show specific measurements on laboratory tests (MFI greater than 1000 on special blood tests)
  • Must have stable kidney function when these new antibodies are detected: - Kidney function test (eGFR) should not vary more than 20% compared to the previous 3 months - Protein in urine test must show less than 0.5 grams of protein per gram of creatinine
  • Must have evidence of early rejection in kidney biopsy (active sABMR) with minimal damage to kidney structures (classified as very slight transplant glomerulopathy)
  • Can be either male or female

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Patients who have not undergone a kidney transplant
  • Patients without donor specific antibodies (proteins that can attack the transplanted kidney)
  • Patients who do not have subclinical antibody mediated rejection (early stage of transplant rejection without visible symptoms)
  • Patients who cannot take belatacept or tacrolimus (anti-rejection medications)
  • Patients who are pregnant or breastfeeding
  • Patients with severe infections or active diseases that could interfere with the study medications
  • Patients participating in other clinical trials
  • Patients unable to provide informed consent
  • Patients with known allergies to study medications
  • Patients with significant liver disease or abnormal liver function
  • Patients with uncontrolled diabetes
  • Patients with active cancer or history of cancer in the past 5 years
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Investigated drugs

Belatacept is a medication that helps prevent organ rejection in kidney transplant patients. It works by suppressing the immune system to reduce the risk of the body attacking the transplanted kidney. It is specifically used to treat patients who have developed antibodies against their donor kidney, even when they don't show obvious symptoms of rejection. Tacrolimus is a commonly used anti-rejection medication that also works by suppressing the immune system. It helps prevent the body from rejecting the transplanted kidney by controlling the immune system's response. It is considered a standard treatment option for kidney transplant recipients and is often used in combination with other medications to prevent organ rejection. Both medications are used as part of a standard care regimen for kidney transplant patients who show signs of developing antibodies against their donor organ, even before obvious rejection symptoms appear.

What is already known about the treatment

  • Belatacept

    A biological immunosuppressant medication administered through intravenous infusion, specifically designed for preventing organ rejection in kidney transplant patients. This drug works by selectively blocking T-cell activation in the immune system, which helps prevent the body from attacking the transplanted kidney. Belatacept belongs to the class of selective T-cell costimulation blockers and represents a newer alternative to traditional calcineurin inhibitors like tacrolimus. The medication is particularly effective in managing subclinical antibody-mediated rejection and helps control donor-specific antibodies that can develop after kidney transplantation.

  • Tacrolimus

    A powerful immunosuppressive medication typically administered orally or intravenously, commonly used to prevent organ rejection in kidney transplant recipients. It works by inhibiting calcineurin, which reduces T-cell activation and suppresses the immune system's response to the transplanted organ. As a cornerstone medication in transplant medicine, tacrolimus belongs to the calcineurin inhibitor class and is considered the standard of care in preventing organ rejection, though it requires careful monitoring of blood levels to maintain effectiveness while minimizing side effects.

Investigated diseases

  • Kidney Transplant Rejection

    A condition where the recipient's immune system recognizes the transplanted kidney as foreign and attacks it. The process can develop slowly over time (chronic rejection) or occur rapidly (acute rejection). The immune system creates antibodies against the donor kidney, leading to inflammation and potential damage to the transplanted organ. This condition can cause the transplanted kidney to function less effectively over time. The body produces specific antibodies called donor-specific antibodies (DSA) that target the transplanted kidney's tissues.

  • Antibody-Mediated Rejection (ABMR)

    A specific type of transplant rejection where antibodies produced by the recipient's immune system attack the blood vessels of the transplanted kidney. This condition can develop without immediate symptoms (subclinical ABMR) or with clear clinical signs. The process involves the formation of antibodies that specifically target the donor organ's tissues. These antibodies can cause inflammation and damage to the blood vessels within the transplanted kidney.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516527-13-00Protocol code2022/0342/HPEstimated enrolment290 patientsSponsorCentre Hospitalier Universitaire Rouen

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).