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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.04.2026

Trial locations

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.

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 ID:
2025-524834-24-00
Protocol code:
RC24-0546
Trial Phase:
Human Pharmacology (Phase I) – Other

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