ANAKINRA for Pancreas transplant | Type 1 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Patients admitted to Nantes University Hospital for a pancreatic transplant (alone or combined with a kidney transplant)\n- Pancreatic transplant priority level: 1, 2 or 3.\n- Age ≥ 18 years\n- Affiliated with the social security system\n- Written consent to participate in the study\n- Contraceptive measures and negative pregnancy test"}

Exclusion criteria

• {"criterion_text":"- Patients under guardianship/curatorship\n- Patients under judicial protection\n- Pregnant or breastfeeding women\n- Positive tuberculin Quantiferon test in the last 12 months.\n- Hepatitis B viral replication in the last 12 months\n- History of known hypersensitivity to Anakinra or any of the excipients or to proteins derived from E. coli\n- Neutropenia < 1500/mm3 prior to transplantation (current assessment)\n- Patient unable to understand and speak French\n- Patient participating in another interventional study (excluding RIRCM)"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Assessment of type, severity and counts (and percentages) of adverse events during the first year post-transplantation; particular identification and counting of severe infections (defined as bacterial, viral, fungal or parasitic infections that are life‑threatening and/or require hospitalisation), documentation of rejection proven by biopsy, and measurement of graft survival with comparison to a historical control cohort (DIVAT Nantes Cohort)."}

Secondary endpoints

• {"endpoint_text":"- Patient survival will be determined by patients who are alive one year after pancreatic transplantation.","definition_or_measurement_approach":"Determination of survival status at one year post-transplantation (alive vs deceased)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite definition of pancreatic graft failure assessed at one year post-transplant: initiation of daily insulin, pancreatic graft removal (transplantectomy), pancreatic retransplantation or islet cell transplantation."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Biochemical and clinical assessments (C-peptide, fasting glucose, insulin needs, HbA1c, OGTT) at one year to calculate β2 score and Igls criteria."}
• {"endpoint_text":"- Assessment of creatinine levels, estimated glomerular filtration rate (CKD-EPI formula) and proteinuria one year after simultaneous kidney-pancreas transplantation.","definition_or_measurement_approach":"Laboratory measures (serum creatinine, eGFR using CKD-EPI, proteinuria) at one year for participants with simultaneous kidney-pancreas transplant."}
• {"endpoint_text":"- Occurrence of severe bacterial infectious complications, i.e. requiring hospitalisation.","definition_or_measurement_approach":"Recording of bacterial infections that required hospitalisation during follow-up; counted as severe bacterial infectious complications."}
• {"endpoint_text":"- Occurrence of CMV viraemia, asymptomatic and/or associated with CMV disease (i.e. organ damage related to CMV replication: haematological, digestive, hepatic or pulmonary).","definition_or_measurement_approach":"Detection of CMV viraemia and documentation of CMV disease manifestations (haematological, digestive, hepatic, pulmonary) during follow-up."}
• {"endpoint_text":"- Occurrence of BK virus viremia, asymptomatic and/or associated with BK virus nephropathy confirmed by biopsy.","definition_or_measurement_approach":"Detection of BK virus viremia and confirmation of BK virus nephropathy by biopsy when present."}
• {"endpoint_text":"- Occurrence of a proven fungal infection.","definition_or_measurement_approach":"Documentation of proven fungal infections during follow-up (microbiological/clinical confirmation)."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Pancreatic rejection confirmed by pancreatic biopsy per Banff criteria, or renal biopsy evidence with supportive clinical/laboratory signs (lipasemia >3x normal, unexplained inflammatory syndrome, unexplained hyperglycaemia)."}
• {"endpoint_text":"- Occurrence of renal graft rejection confirmed by renal biopsy (according to Banff criteria).","definition_or_measurement_approach":"Renal graft rejection confirmed by renal biopsy using Banff criteria."}
• {"endpoint_text":"- Occurrence of graft-directed antibodies at one year, considered significant with a Mean Fluorescence Index (MFI) > 500.","definition_or_measurement_approach":"Assessment of donor-specific/graft-directed antibodies at one year; considered significant if MFI > 500."}

France

Earliest CTIS Part Ii Submission Date

02-02-2026

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

38

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France