Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

"IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ"

This study is for people who are having a pancreas transplant. Pancreas transplants are a great way to help people with diabetes, but sometimes the body can reject the new pancreas or develop blood clots shortly after surgery. This research is looking at a medicine called Anakinra, which works by blocking a specific protein in the body, to see if it can help prevent these problems. Researchers want to find out if Anakinra is safe to use right after a pancreas transplant and if it can help the new pancreas work better for longer. This is an early-stage study, meaning it's one of the first times this medicine is being tested for this specific use. It will help doctors understand if Anakinra could be a helpful addition to the care people receive after a pancreas transplant to improve their health and well-being.

At a glance

Status

Not yet recruiting

Phase

PHASE1, PHASE2

Sponsor

Nantes University Hospital

Enrolment target

Start

01 May 2026

Estimated completion

01 Nov 2029

Pancreatic Transplant

What is this study about?

When someone with diabetes receives a new pancreas, it can be life-changing, as it helps their body make its own insulin again. However, sometimes the body's immune system can try to reject the new pancreas, or blood clots can form quickly after the operation, which can cause serious problems and even lead to the pancreas not working. Doctors are always looking for ways to make pancreas transplants more successful and last longer.

This study, called ILIPO, is exploring a medicine called Anakinra. This medicine helps by blocking a protein in the body that can cause inflammation and lead to these problems, especially blood clots (which doctors call "immunological thrombosis"). Anakinra has been used successfully in combination with other medicines to help with similar issues in people who have received special cells from a pancreas transplant, but not directly for a whole pancreas transplant until now.

The main goal of this study is to check if Anakinra is safe for people to take immediately after they have a pancreas transplant. By finding out if it's safe and if it helps prevent early problems, doctors hope to improve the success rate of pancreas transplants and give people a better chance at a healthier life free from diabetes.

Key takeaways

This study is testing a new medicine called Anakinra for people getting a pancreas transplant.
The main goal is to see if Anakinra is safe and can prevent problems like rejection or blood clots right after surgery.
It's an early-stage study, focusing on the immediate period after transplantation.
Participants will receive Anakinra injections and will be closely monitored by medical staff.
The study aims to improve the long-term success of pancreas transplants.

Who may be eligible?

To join this study, you must be an adult aged 18 or older and be receiving a pancreas transplant at Nantes University Hospital in France. This can be a pancreas transplant by itself or combined with a kidney transplant. You must also be covered by the French social security system and be willing to give written permission to take part.

For women, you need to either be using effective birth control and have a negative pregnancy test, be past menopause (usually over 50 and not had a period for at least a year), or have had certain surgical procedures that prevent pregnancy. Men need to agree to use condoms if their partner could get pregnant during the study and for a few months after.

You cannot join the study if you are pregnant or breastfeeding, have certain serious medical conditions like active tuberculosis or hepatitis B, or have had a bad reaction to Anakinra or similar medicines in the past. If your blood count for a specific type of white blood cell (neutrophils) is too low before your transplant, you also can't participate. You must be able to understand and speak French, and you can't be taking part in another medical study that involves trying a new treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older.
I am having a pancreas transplant at Nantes University Hospital.
I am covered by the French social security system.
I can understand and speak French.
I am not pregnant or breastfeeding.
I have not had a serious reaction to Anakinra or similar medicines before.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, Anakinra, right after your pancreas transplant. This medicine is given as an injection. The main focus of the study is to closely monitor your health and how you react to the medicine in the days and weeks following your transplant. This means you’ll have regular check-ups, blood tests, and medical assessments conducted by the hospital staff.

The research team will be checking for any side effects from the Anakinra and will also monitor how your new pancreas is working. While the detailed schedule isn't fully described, you can expect to have more frequent medical evaluations than someone not in the study, especially during your hospital stay and potentially for a period after you go home. The total duration of your participation will involve the immediate post-transplant period, with follow-up to check on your progress.

Potential risks and benefits

Participating in this study might offer a potential benefit if Anakinra helps your new pancreas work better and for longer, by reducing the risk of rejection or blood clots. However, as with any medical treatment, there are potential risks, including side effects from Anakinra or potential complications from the transplant itself. Being in a study means you'll be monitored very closely, which can be reassuring. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU Nantes
Verified postcode
Nantes, France

Common questions

What is Anakinra?

Anakinra is a medicine that helps block a specific protein in your body that can cause inflammation and lead to problems like blood clots after an organ transplant.

Why is this study important?

Pancreas transplants are amazing, but sometimes the body can reject the new organ or blood clots can form. This study hopes to find out if Anakinra can safely help prevent these issues and make transplants more successful.

Will I still receive my normal transplant care?

Yes, you will still receive all the standard medical care for your pancreas transplant. Anakinra is being given in addition to your usual treatment.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting your medical care at the hospital.

Where is this study taking place?

This study is being conducted at Nantes University Hospital in France.

How to find out more

Christophe MASSET

christophe.masset@chu-nantes.fr 2.76.64.39.61 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.