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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Anakinra 100Mg/0.67Ml Inj Syringe
  Safety of Anakinra in the immediate aftermath of pancreatic transplantation

Первичные конечные точки

• evaluate the safety of IL-1β in a pilot study of patients who have undergone a pancreas transplant [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Assess patient survival one year after transplantation [Срок оценки: 1 year]
• Assess pancreatic graft survival one year post-transplant [Срок оценки: 1 year]
• Assess pancreatic graft function [Срок оценки: 1 year]
• Assess pancreatic graft function [Срок оценки: 1 year post-transplant]
• Assess pancreatic graft function [Срок оценки: 1 year]
• Assess pancreatic graft function [Срок оценки: 1 year]
• Assess pancreatic graft function [Срок оценки: 1 year]
• Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation) [Срок оценки: 1 year]
• Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation) [Срок оценки: 1 year]
• Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation) [Срок оценки: 1 year]
• Assess the occurrence of severe bacterial infections [Срок оценки: up to 1 year]
• Assess the occurrence of Cytomégalovirus infection [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU Nantes — Nantes

Идентификаторы

NCT: NCT07503834 · RC24_0546

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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