"IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ"

Phase 2Not Yet RecruitingNCT07503834

Nantes University Hospital15 enrolled

Overview

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

Pancreas transplantation is the treatment of choice for curing diabetes by restoring long-term endogenous insulin secretion. However, the increased risk of rejection compared to other transplants, and especially the risk of early graft loss due to immunological thrombosis, are major obstacles to this procedure. IL-1β blockade is commonly used in islet transplantation, as it has demonstrated a benefit in terms of graft survival when administered immediately postoperatively, in combination with TNFα blockade18. The ILIPO study therefore aims to evaluate the safety of anti-IL-1β treatment as an adjunct to the regimen currently used in our department for pancreatic transplants.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Transplant

Interventions

Anakinra 100Mg/0.67Ml Inj SyringeDRUG

Safety of Anakinra in the immediate aftermath of pancreatic transplantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

CHU Nantes

Nantes, France

Outcomes

Primary Outcomes

evaluate the safety of IL-1β in a pilot study of patients who have undergone a pancreas transplant

Type, severity (CTACAE, and 2012 KDIGO classification for kidney damage) and number (and percentage) of adverse events occurring within the first year following pancreatic transplantation, with a particular focus on severe infections (bacterial, viral, fungal, or parasitic infections that are life-threatening and/or require hospitalization), the occurrence of rejection confirmed by biopsy, and graft survival compared to a historical control cohort (DIVAT Nantes Cohort).

Time frame: 1 year

Secondary Outcomes

Assess patient survival one year after transplantation

Patient survival will be determined by the patients who are still alive one year after pancreatic transplantation.

Time frame: 1 year

Assess pancreatic graft survival one year post-transplant

Pancreatic transplant failure is defined as the occurrence of any of the following criteria within one year of transplantation: The need for daily insulin treatment and/or removal of the pancreatic graft (i.e., pancreatic graft transplantectomy) and/or pancreatic retransplantation and/or islet of Langhans transplantation.

Time frame: 1 year

Assess pancreatic graft function

Assessment of C-peptide (ng/mL) one year after transplantation to calculate the β2 score and IGLS criteria.

Time frame: 1 year

Assess pancreatic graft function

Assessment of fasting blood glucose (mmol/l) one year after transplantation to calculate the β2 score and IGLS criteria.

Time frame: 1 year post-transplant

Assess pancreatic graft function

Central Contacts

Christophe MASSET

CONTACT

2.76.64.39.61 christophe.masset@chu-nantes.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.