"IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ"
ConditionPancreatic Transplant
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient under guardianship/curatorship
Patient under judicial protection
Pregnant or breastfeeding woman
Positive tuberculin skin test in the last 12 months
Trial design
Design model
Single group
Treatments tested in this trial
Anakinra 100Mg/0.67Ml Inj Syringe
DrugSafety of Anakinra in the immediate aftermath of pancreatic transplantation
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: AnakinraExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 year2
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 year3
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 year4
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-transplantSponsors and contacts
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Source ClinicalTrials.gov