"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 range18 Years
SexALL
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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…
What they're measuring
1
evaluate the safety of IL-1β in a pilot study of patients who have undergone a pancreas transplant