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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Transplant
• Intervention / Treatment: Drug: Anakinra 100Mg/0.67Ml Inj Syringe

Detailed Description

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
• Enrollment (Estimated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Christophe MASSET; Phone Number: +33 2.76.64.39.61; Email: christophe.masset@chu-nantes.fr

Study Locations

• France
  • Nantes, France
    • CHU Nantes
    • Contact: Christophe MASSET; Phone Number: +33 2.76.64.39.61; Email: christophe.masset@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anakinra	Drug: Anakinra 100Mg/0.67Ml Inj Syringe; Safety of Anakinra in the immediate aftermath of pancreatic transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess patient survival one year after transplantation	Patient survival will be determined by the patients who are still alive one year after pancreatic transplantation.	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.	1 year
Assess pancreatic graft function	Assessment of C-peptide (ng/mL) one year after transplantation to calculate the β2 score and IGLS criteria.	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.	1 year post-transplant
Assess pancreatic graft function	Assessment of insulin requirements (number of units) one year after transplantation to calculate the β2 score and IGLS criteria.	1 year
Assess pancreatic graft function	Assessment of HbA1c (percent) one year after transplantation to calculate the β2 score and IGLS criteria.	1 year
Assess pancreatic graft function	Assessment of an oral glucose tolerance test (normal/anormal) one year after transplantation.	1 year
Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation)	Assessment of serum creatinine levels (mmol/24h) one year after simultaneous kidney-pancreas transplantation.	1 year
Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation)	Assessment of estimated glomerular filtration rate (ml/min/1.73m²) (using the CKD-EPI formula) one year after simultaneous kidney-pancreas transplantation.	1 year
Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation)	Assessment of proteinuria (mg/24h) one year after simultaneous kidney-pancreas transplantation.	1 year
Assess the occurrence of severe bacterial infections	The occurrence of severe bacterial infections, i.e. those requiring hospitalisation.	up to 1 year
Assess the occurrence of Cytomégalovirus infection	Occurrence of CMV viremia, whether asymptomatic and/or associated with CMV disease (i.e. organ involvement linked to CMV replication: haematological, gastrointestinal, hepatic or pulmonary).	up to 1 year
Assess the occurrence of BK virus infection	Occurrence of BK virus viremia, whether asymptomatic and/or associated with BK virus nephropathy confirmed by biopsy.	up to 1 year
Assess the occurrence of fungal infection		up to 1 year
Assess the occurrence of pancreatic graft rejection	Occurrence of pancreatic rejection confirmed by pancreatic biopsy (according to the Banff criteria) and/or by renal biopsy in the presence of findings consistent with associated pancreatic rejection	up to 1 year
Assess the occurrence of renal graft rejection (in the case of simultaneous kidney-pancreas transplantation)		up to 1 year
Assess the occurrence of graft-specific antibodies	Development of anti-graft antibodies at one year, considered significant where the Mean Fluorescence Index is > 500.	1 year

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Immunothrombosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Inflammation; Hematologic Diseases; Embolism and Thrombosis; Blood Coagulation Disorders; Thrombosis; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Thromboinflammation; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Intercellular Signaling Peptides and Proteins; Cytokines; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: RC24_0546

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No