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Study of Tocilizumab Treatment for Chronic Antibody-Mediated Rejection in Kidney Transplant Recipients

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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 chronic active antibody-mediated rejection, a condition that can occur in people who have received a kidney transplant. This type of rejection happens when the body's immune system creates antibodies that attack the transplanted kidney, which can lead to decreased kidney function over time. The study will test a medication called tocilizumab (RoActemra), which is given as an injection under the skin.

The purpose of the study is to determine if adding tocilizumab to standard care treatment works better than standard care alone in preserving kidney function in transplant recipients who have this type of rejection. The medication will be given as a 162 mg injection under the skin for a period of 24 months.

During the study, participants will have their kidney function monitored through blood tests that measure how well their kidneys are filtering waste products from their blood. They will also have kidney tissue samples taken and undergo other medical tests to check their overall health and the condition of their transplanted kidney. The total duration of monitoring will last for 36 months, with regular check-ups to assess the kidney's function and the participant's general health.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive RoActemra (tocilizumab) through subcutaneous injection, which means the medication is given under the skin

    The treatment period will last for 24 months

    The medication comes in the form of a pre-filled syringe containing 162 mg of the active substance

  2. Step 2

    Regular monitoring - first month

    Your kidney function will be checked after the first month of treatment

    The kidney function test measures your estimated glomerular filtration rate (eGFR), which shows how well your kidneys are working

  3. Step 3

    Ongoing monitoring - every 3 months

    Your kidney function will be checked every 3 months for up to 36 months

    Blood tests will be performed at an approved laboratory

    The tests will measure your kidney function and monitor how well the treatment is working

  4. Step 4

    Scheduled biopsies

    You will need kidney biopsies at 12 and 24 months after starting treatment

    These biopsies help monitor changes in your transplanted kidney

  5. Step 5

    Additional tests

    Your urine will be tested at 12, 24, and 36 months to check protein levels

    Special kidney function tests using iohexol will be performed at 12, 24, and 36 months

    Your antibody levels will be measured at 12, 24, and 36 months

  6. Step 6

    Follow-up period

    After the 24-month treatment period, you will continue to be monitored for an additional 12 months

    Regular check-ups will continue until the 36-month mark

    The study will track your health status and kidney function throughout this period

Who can join the trial?

10 criteria

  • Must provide written informed consent to participate in the study
  • Must be a recipient of a kidney transplant from either a living or deceased donor
  • Must be at least 18 years old
  • Must be at least 6 months after kidney transplantation when entering the study
  • Must have a confirmed diagnosis of active antibody-mediated rejection (a condition where the body's immune system attacks the transplanted kidney) proven by tissue examination
  • Must have a kidney function test (eGFR) showing at least 20 ml/min/1.73 m² within the past month
  • Must be EBV positive (have evidence of past Epstein-Barr virus infection)
  • For women who can become pregnant: must use effective birth control and have a negative pregnancy test
  • If previously had COVID-19, must:
    • Have no symptoms for at least 1 month before initial screening
    • Be on regular transplant medications for at least 1 month before starting the study

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Pregnant or breastfeeding women
  • History of organ transplant rejection within the last 3 months
  • Active or chronic infections, including tuberculosis, hepatitis B, hepatitis C, or HIV
  • Severe liver disease or abnormal liver function tests
  • Uncontrolled high blood pressure
  • History of cancer in the past 5 years (except successfully treated skin cancer)
  • Major surgery planned within the next 6 months
  • Current participation in other clinical trials
  • Serious heart conditions or recent heart attack
  • Severe blood disorders or significantly low blood cell counts
  • Mental health conditions that could interfere with following study procedures
  • Known allergic reactions to study medications
  • Immunosuppressive therapy (medications that weaken the immune system) that differs from standard treatment
  • Substance abuse or addiction that could affect study participation
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Investigated drugs

Tocilizumab (TCZ) A medication that works by blocking a specific protein in the immune system. It is used to reduce inflammation and prevent organ rejection in kidney transplant patients. In this trial, it is being tested as an additional treatment for patients who are experiencing rejection of their transplanted kidney, specifically for a condition called antibody-mediated rejection. Standard of Care (SOC) The current established treatment that patients typically receive for kidney transplant rejection. This includes medications and procedures that are already approved and commonly used to prevent and treat organ rejection. In this trial, some patients will receive only the standard of care, while others will receive standard of care plus tocilizumab.

What is already known about the treatment

Tocilizumab (TCZ) - A biologic medication administered through intravenous infusion or subcutaneous injection, primarily known under the trade names Actemra and RoActemra. It is an immunosuppressive drug that works by blocking interleukin-6 receptors, thereby reducing inflammation in the body. Currently being studied in clinical trials for treating chronic active antibody-mediated rejection in kidney transplant recipients, while already approved for conditions like rheumatoid arthritis and giant cell arteritis. This monoclonal antibody belongs to the class of disease-modifying antirheumatic drugs (DMARDs) and is being evaluated alongside standard of care (SOC) treatment to potentially improve kidney transplant outcomes by preserving graft function.

Investigated diseases

Chronic active antibody-mediated rejection - A condition that occurs after kidney transplantation where the recipient's immune system produces antibodies that attack the transplanted kidney. This process develops gradually over time, causing progressive damage to the transplanted organ's blood vessels and tissue. The condition typically involves the formation of donor-specific antibodies that react against the transplanted kidney. It leads to inflammation within the kidney tissue and gradually affects the organ's filtering function. The damage accumulates slowly, causing changes in the kidney's structure and deterioration of its function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510615-29-00Estimated enrolment50 patientsSponsorVaestra Goetalandsregionen

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