IL-1β blocker after pancreatic transplant to help prevent graft thrombosis
Official title: "IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ (ILIPO)"
Run by Nantes University Hospital · NCT07503834 · Data updated 2026-11-12
This trial tests whether adding Anakinra right after pancreatic transplant is safe for patients to see if it helps protect the new pancreas.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 2 sites (Nantes and 1 other locations) |
| Status | Recruiting |
| Started | October 7, 2026 |
| Main results expected | April 7, 2029 |
| Study ends | April 7, 2029 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07503834 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing pancreatic (± kidney) transplantation at Nantes University Hospital who meet graft rank and consent criteria.
✕Probably not a fit
Patients with adverse reactions to IL-1β blockade or those who do not experience thrombotic risk reduction may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, non-randomized Phase I/II study conducted at a single center to evaluate the safety of Anakinra given immediately after pancreatic transplantation. Participants may be adults undergoing pancreatic transplant, with or without a kidney transplant. The study uses a 100 mg Anakinra injection and follows standard post-transplant care to monitor for safety signals in the early post-transplant period.
Why it matters
Potential benefit: If safe and effective, Anakinra could reduce early graft loss due to immunothrombosis after pancreatic transplantation.
How similar studies have gone: IL-1β blockade has shown graft-survival benefits in islet transplantation when used postoperatively in combination therapies, but this exact approach in whole-organ pancreatic transplantation is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
CHU de Nantes - Service ITUN
Nantes, France Recruiting -
CHU Nantes - Service de réa
Nantes, France Active not recruiting
Study contacts
- Study coordinator: Christophe MASSET
- Email: christophe.masset@chu-nantes.fr
- Phone: 2.76.64.39.61
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.