New drug aims to protect pancreas transplants
NCT ID NCT07503834
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHU Nantes
Nantes, France