IL-1β blockade to prevent Immunothrombosis in recipients of a Pancreatic Organ (ILIPO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-03-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU de Nantes - appel d'offre interne

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To evaluate the safety of IL-1β in a pilot series of pancreatic transplant patients.

Secondary objectives 11

1. Assess patient survival one year post-transplantation.
2. Assess pancreatic graft survival one year post-transplantation
3. Assess pancreatic graft function
4. Assess kidney graft function (if simultaneous kidney-pancreas transplant)
5. Assess the occurrence of severe bacterial infections
6. Assess the occurrence of CMV infection
7. Assess the occurrence of BK virus infection
8. Assess the occurrence of fungal infection
9. Assess the occurrence of pancreatic graft rejection
10. Assess the occurrence of renal graft rejection (if simultaneous kidney-pancreas transplant)
11. Assess the occurrence of graft-directed antibodies

Conditions and MedDRA coding

diabetic patients pancreatic transplant

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 9

1. Patients under guardianship/curatorship
2. Patients under judicial protection
3. Pregnant or breastfeeding women
4. Positive tuberculin Quantiferon test in the last 12 months.
5. Hepatitis B viral replication in the last 12 months
6. History of known hypersensitivity to Anakinra or any of the excipients or to proteins derived from E. coli
7. Neutropenia < 1500/mm3 prior to transplantation (current assessment)
8. Patient unable to understand and speak French
9. Patient participating in another interventional study (excluding RIRCM)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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)

Secondary endpoints 11

1. Patient survival will be determined by patients who are alive one year after pancreatic transplantation.
2. 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.
3. 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.
4. Assessment of creatinine levels, estimated glomerular filtration rate (CKD-EPI formula) and proteinuria one year after simultaneous kidney-pancreas transplantation.
5. Occurrence of severe bacterial infectious complications, i.e. requiring hospitalisation.
6. Occurrence of CMV viraemia, asymptomatic and/or associated with CMV disease (i.e. organ damage related to CMV replication: haematological, digestive, hepatic or pulmonary).
7. Occurrence of BK virus viremia, asymptomatic and/or associated with BK virus nephropathy confirmed by biopsy.
8. Occurrence of a proven fungal infection.
9. 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).
10. Occurrence of renal graft rejection confirmed by renal biopsy (according to Banff criteria).
11. Occurrence of graft-directed antibodies at one year, considered significant with a Mean Fluorescence Index (MFI) > 500.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

5 Allee De L Ile Gloriette, Cs 69301 Cs 69301

City

Nantes Cedex 1

Postcode

44093

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Christophe Masset

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Christophe Masset

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications