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Study of anakinra and a drug combination to prevent blood clots in patients receiving a pancreatic transplant

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 individuals who have undergone a pancreatic transplant, which is a surgical procedure to replace a damaged pancreas with a healthy organ from a donor. The goal of the study is to evaluate the safety of using anakinra to prevent immunothrombosis, a process where the immune system causes blood clots to form within an organ. Participants in the study may also be taking background medications such as etanercept, mycophenolic acid, or tacrolimus to help prevent the body from attacking the new organ.

During the study, the focus is on monitoring how the body responds to the new organ and the medications over the first year. This includes observing for signs of rejection, which occurs when the immune system identifies the transplanted organ as foreign and tries to destroy it. The study also tracks the occurrence of various infections and monitors how well the new pancreas functions by checking blood sugar levels and the need for insulin.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    An injection of kineret (active substance: anakinra) is administered under the skin. this is the test medication used to study the effects of blocking a specific part of the immune system.

    Background medications are continued during the study. these include erelzi (active substance: etanercept) given as an injection under the skin, myfortic (active substance: mycophenolic acid) taken as a pill, and prograf (active substance: tacrolimus) taken as a capsule.

  2. Step 2

    Monitoring and evaluation

    During the first year following the pancreatic transplant, health status is monitored to identify any adverse events, such as severe infections (caused by bacteria, viruses, fungi, or parasites) or organ rejection.

    Medical procedures like biopsies (taking a small sample of tissue for examination) may be performed to check for signs of organ rejection.

    At the one-year mark, several health measurements are conducted, including blood tests to check blood glucose (sugar) levels, insulin needs, and c-peptide (a marker of insulin production).

    An oral glucose tolerance test (a test to see how the body handles sugar) is performed at the one-year point.

    If a kidney was also transplanted at the same time, kidney function is evaluated through tests for creatinine levels, glomerular filtration rate (a measure of how well the kidneys filter blood), and proteinuria (the presence of protein in the urine).

    Blood tests are used to monitor for specific viruses, such as cmv and bk virus, as well as the presence of certain antibodies (proteins that the immune system produces).

Who can join the trial?

6 criteria

  • You must be a patient being admitted to the Nantes University Hospital for a pancreatic transplant, which is a surgery to replace a damaged pancreas with a healthy one from a donor. This may be done by itself or along with a kidney transplant.
  • Your priority level for receiving a pancreas must be 1, 2, or 3.
  • You must be 18 years of age or older.
  • You must be covered by the social security system.
  • You must provide written consent, which means signing a document that shows you agree to take part in the study.
  • You must use contraceptive measures, which are methods used to prevent pregnancy, and have a negative pregnancy test.

Who cannot join the trial?

9 criteria

  • People who are under guardianship or curatorship, which means a legal guardian makes decisions for them.
  • People who are under judicial protection, meaning they have legal restrictions placed on them by a court.
  • Women who are pregnant or breastfeeding.
  • People who had a positive tuberculin Quantiferon test in the last 12 months, which is a blood test used to check if you have been infected with the bacteria that causes tuberculosis (a serious lung disease).
  • People who had Hepatitis B viral replication in the last 12 months, which means the Hepatitis B virus (a virus that attacks the liver) was actively multiplying in their body.
  • People with a known hypersensitivity, or allergy, to Anakinra, any of the excipients (inactive ingredients used to make a medicine), or to proteins derived from E. coli (substances made from a specific type of bacteria).
  • People with neutropenia, which is a low level of neutrophils (a type of white blood cell that helps the body fight infection), specifically a count lower than 1500/mm3 before their transplant.
  • People who are unable to understand and speak French.
  • People who are already participating in another interventional study, which is a clinical trial where a patient receives a specific treatment or intervention.
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Investigated drugs

  • Anakinra

    is the main medication being tested in this study. It is an injection given under the skin that works to block a specific protein in the body that causes inflammation, which may help prevent blood clots in patients who have received a pancreas transplant.

  • Etanercept

    is a medication used as part of the background treatment. It is an injection given under the skin that helps to reduce inflammation in the body.

  • Mycophenolic acid

    is a medication taken by mouth as a tablet. It is used to help prevent the body's immune system from attacking a transplanted organ.

  • Tacrolimus

    is a medication taken by mouth in capsule form. It works by calming the immune system to help prevent the body from rejecting a new organ.

What is already known about the treatment

  • Anakinra

    This medication is given as a liquid through a small needle under the skin using a pre-filled syringe. It is an established treatment used to manage inflammatory conditions by blocking a specific protein in the body called interleukin-1, which plays a key role in causing swelling and pain. By attaching itself to this protein, it prevents the body's immune system from overreacting. It is classified as an interleukin-1 receptor antagonist.

  • Etanercept

    This medicine is administered as a liquid injection through the skin using a pre-filled syringe. It is a widely used treatment for various autoimmune diseases and works by acting like a sponge to soak up certain inflammatory proteins in the blood before they can cause damage. This prevents the immune system from attacking the body's own tissues. It belongs to a group of drugs known as tumor necrosis factor (TNF) inhibitors.

  • Mycophenolic acid

    This medication is taken orally in the form of special tablets designed to dissolve in the intestines rather than the stomach. It is commonly used to prevent the body from rejecting transplanted organs by stopping the production of certain immune cells that would otherwise attack the new organ. It works by interfering with the DNA replication process required for these immune cells to multiply. It is classified as an immunosuppressant.

  • Tacrolimus

    This drug is swallowed in the form of a hard capsule. It is a well-known medication used to prevent organ rejection after a transplant by calming down the immune system. At a molecular level, it works by blocking specific signals within immune cells that are necessary for them to become active and attack foreign tissue. It is categorized as a calcineurin inhibitor.

Investigated diseases

Diabetes mellitus - This is a condition where the body cannot properly regulate blood sugar levels. It occurs because the pancreas does not produce enough insulin or the body cannot use it effectively. Over time, high blood sugar levels can lead to various complications. The condition typically requires ongoing management to maintain stable glucose levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-524834-24-00Protocol codeRC24-0546Estimated enrolment15 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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