"IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ" (NCT07503834) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
"IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ"
France15 participantsStarted 2026-05-01
Plain-language summary
A prospective, open-label, uncontrolled, non-randomized, single-center Phase I/II clinical trial evaluating the safety of Anakinra in the immediate post-transplant period following pancreatic transplantation
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/curatorshi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
evaluate the safety of IL-1β in a pilot study of patients who have undergone a pancreas transplant