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New drug aims to protect pancreas transplants

NCT ID NCT07503834

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests the safety of a drug called Anakinra in 15 people who have just received a pancreas transplant. The goal is to see if blocking a certain immune signal can prevent dangerous blood clots and improve transplant success. Researchers will closely monitor for side effects, especially severe infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anakinra
What this could lead to
If safe, this could point toward a way to reduce transplant complications and improve graft survival.
What could go wrong
This is a very early, small (15 people), open-label trial with no control group, so results may not be reliable or generalizable. There is also a risk of severe infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient admitted to Nantes University Hospital for a pancreatic transplant (alone or combined with a kidney transplant) * Pancreatic graft rank: 1, 2 or 3 * Affiliated with the social security scheme * Written consent to participate in the study * Women must meet one of the following criteria at the time of inclusion: * use adequate contraceptive measures and have a negative pregnancy test (urine test) before receiving the first dose of the trial drug * or be postmenopausal (aged over 50 with amenorrhoea for at least 12 months after stopping all exogenous hormone treatments); * or (if under 50 years of age) have been amenorrhoeic for at least 12 months after stopping exogenous hormone treatments and with luteinising hormone (LH) and follicle-stimulating hormone (FSH) levels corresponding to postmenopausal levels; * or have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented). * Male patients with a partner must be willing to use male contraception (condoms) during the trial and for up to 90 days after the last dose of the trial drug. partners of male subjects participating in the trial may use hormonal contraceptives as one of the acceptable methods of contraception, as they will not be receiving the trial drug (i.e., oral hormonal contraception, cap, diaphragm, or sponge with spermicide). Exclusion Criteria: * Patient under guardianship/curatorship * Patient under judicial protection * Pregnant or breastfeeding woman * Positive tuberculin skin test in the last 12 months * Hepatitis B viral replication in the last 12 months * History of known hypersensitivity to Anakinra or any of its excipients or to proteins derived from E. coli * Neutropenia \< 1500/mm3 prior to transplantation (daily assessment) * Patient unable to understand and speak French * Patient participating in another interventional study (outside RIRCM)

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Conditions

The condition(s) this trial relates to.

Thromboinflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Nantes

    Nantes, France