IL-1β blockade to prevent Immunothrombosis in recipients of a Pancreatic Organ (ILIPO)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the type, severity, number (and percentage) of adverse events occurring in the first year after pancreatic transplantation, with a particular focus on severe infections (bacterial, viral, fungal or parasitic infections that are life-threatening and/or require hospitalisation), the occurrence of rejection proven by biopsy, and graft survival compared to a historical control cohort (DIVAT Nantes Cohort)
研究概览
简要总结
To evaluate the safety of IL-1β in a pilot series of pancreatic transplant patients.
研究设计
- 分配方式
- Na
- 主要目的
- Overall trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to Nantes University Hospital for a pancreatic transplant (alone or combined with a kidney transplant)
- •Pancreatic transplant priority level: 1, 2 or
- •Age ≥ 18 years
- •Affiliated with the social security system
- •Written consent to participate in the study
- •Contraceptive measures and negative pregnancy test
排除标准
- •Patients under guardianship/curatorship
- •Patients under judicial protection
- •Pregnant or breastfeeding women
- •Positive tuberculin Quantiferon test in the last 12 months.
- •Hepatitis B viral replication in the last 12 months
- •History of known hypersensitivity to Anakinra or any of the excipients or to proteins derived from E. coli
- •Neutropenia < 1500/mm3 prior to transplantation (current assessment)
- •Patient unable to understand and speak French
- •Patient participating in another interventional study (excluding RIRCM)
研究组 & 干预措施
Myfortic 360 mg gastrorezistentné tablety
干预措施: Myfortic 360 mg gastrorezistentné tablety (Drug)
Erelzi 25 mg solution for injection in pre-filled syringe.
干预措施: Erelzi 25 mg solution for injection in pre-filled syringe. (Drug)
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
干预措施: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe. (Drug)
PROGRAF 1 mg capsule
干预措施: PROGRAF 1 mg capsule (Drug)
结局指标
主要结局
The primary endpoint will be the type, severity, number (and percentage) of adverse events occurring in the first year after pancreatic transplantation, with a particular focus on severe infections (bacterial, viral, fungal or parasitic infections that are life-threatening and/or require hospitalisation), the occurrence of rejection proven by biopsy, and graft survival compared to a historical control cohort (DIVAT Nantes Cohort)
The primary endpoint will be the type, severity, number (and percentage) of adverse events occurring in the first year after pancreatic transplantation, with a particular focus on severe infections (bacterial, viral, fungal or parasitic infections that are life-threatening and/or require hospitalisation), the occurrence of rejection proven by biopsy, and graft survival compared to a historical control cohort (DIVAT Nantes Cohort)
次要结局
- Patient survival will be determined by patients who are alive one year after pancreatic transplantation.
- Pancreatic graft failure is determined by the occurrence of one of the following criteria one year after transplantation: Need for daily insulin treatment and/or removal of the pancreatic graft (i.e., pancreas transplantectomy) and/or pancreatic retransplantation and/or islet cell transplantation.
- Evaluation of C-peptide, fasting blood glucose, insulin requirements and HbA1c one year after transplantation to calculate the β2 score and Igls criteria28,29. Evaluation of oral glucose tolerance test (OGTT) one year after transplantation.
- Assessment of creatinine levels, estimated glomerular filtration rate (CKD-EPI formula) and proteinuria one year after simultaneous kidney-pancreas transplantation.
- Occurrence of severe bacterial infectious complications, i.e. requiring hospitalisation.
- Occurrence of CMV viraemia, asymptomatic and/or associated with CMV disease (i.e. organ damage related to CMV replication: haematological, digestive, hepatic or pulmonary).
- Occurrence of BK virus viremia, asymptomatic and/or associated with BK virus nephropathy confirmed by biopsy.
- Occurrence of a proven fungal infection.
- Occurrence of pancreatic rejection defined by pancreatic biopsy (according to Banff criteria) and/or renal biopsy in the presence of evidence of associated pancreatic rejection (i.e., lipasaemia > 3 times normal + unexplained inflammatory syndrome + unexplained hyperglycaemia).
- Occurrence of renal graft rejection confirmed by renal biopsy (according to Banff criteria).
- Occurrence of graft-directed antibodies at one year, considered significant with a Mean Fluorescence Index (MFI) > 500.
研究者
Christophe Masset
Scientific
Centre Hospitalier Universitaire De Nantes