Pancreatic TransplantPhase 1/2ILIPONCT07503834
"IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ"
A Phase 1/2 study testing Anakinra 100Mg/0.67Ml Inj Syringe in people with Pancreatic Transplant, run by Nantes University Hospital at 2 sites in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Transplant
- What is being tested?
- Anakinra 100Mg/0.67Ml Inj Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Oct 2026to 7 Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- Neutropenia < 1500/mm3 prior to transplantation (daily assessment)
- Patient unable to understand and speak French
- Patient participating in another interventional study (outside RIRCM)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 1 recruiting
- Recruiting
CHU de Nantes - Service ITUN
Nantes, 44000
Christophe Masset, Dr, +33 2.76.64.39.61, christophe.masset@chu-nantes.fr
Christophe Masset, Dr
- Active, not recruiting
CHU Nantes - Service de réa
Nantes
About this study
Official title: "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
Read the 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.
- Conditions
- Pancreatic Transplant
- Being tested
- Anakinra 100Mg/0.67Ml Inj Syringe
- Keywords
- Immunothrombosis
- Medical subject headings
- Thromboinflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra 100Mg/0.67Ml Inj SyringeDrug
Safety of Anakinra in the immediate aftermath of pancreatic transplantation
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | Not described Receives: Drug: Anakinra 100Mg/0.67Ml Inj Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (17)
Assess patient survival one year after transplantation
Patient survival will be determined by the patients who are still alive one year after pancreatic transplantation.
Measured: 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.
Measured: 1 year
Assess pancreatic graft function
Assessment of C-peptide (ng/mL) one year after transplantation to calculate the β2 score and IGLS criteria.
Measured: 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.
Measured: 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.
Measured: 1 year
Assess pancreatic graft function
Assessment of HbA1c (percent) one year after transplantation to calculate the β2 score and IGLS criteria.
Measured: 1 year
Assess pancreatic graft function
Assessment of an oral glucose tolerance test (normal/anormal) one year after transplantation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Assess the occurrence of severe bacterial infections
The occurrence of severe bacterial infections, i.e. those requiring hospitalisation.
Measured: 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).
Measured: 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.
Measured: up to 1 year
Assess the occurrence of fungal infection
Measured: 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
Measured: up to 1 year
Assess the occurrence of renal graft rejection (in the case of simultaneous kidney-pancreas transplantation)
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start7 Oct 2026
- Primary completion7 Apr 2029 (estimated)
- Study completion7 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic TransplantStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- the safety of Anakinra in the immediate aftermath of pancreatic transplantation
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503834
- Sponsor's protocol ID
- RC24_0546
- Acronym
- ILIPO
- Status last verified
- Oct 2026
- First submitted
- 17 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ (ILIPO)"
- ClinicalTrials.gov ID
- NCT07503834
- Acronym / sponsor ID
- ILIPO / RC24_0546
- Conditions
- Pancreatic Transplant
- Keywords
- Immunothrombosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- 7 Apr 2029 (estimated)
- Study completion
- 7 Apr 2029 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the safety of Anakinra in the immediate aftermath of pancreatic transplantation
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: Anakinra 100Mg/0.67Ml Inj Syringe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anakinra 100Mg/0.67Ml Inj SyringeSafety of Anakinra in the immediate aftermath of pancreatic transplantation | Drug | Anakinra |
Primary outcome
evaluate the safety of IL-1β in a pilot study of patients who have undergone a pancreas transplant
Time frame: 1 year
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).
17 secondary outcomes
Assess patient survival one year after transplantation
Time frame: 1 year
Assess pancreatic graft survival one year post-transplant
Time frame: 1 year
Assess pancreatic graft function
Time frame: 1 year
Assess pancreatic graft function
Time frame: 1 year post-transplant
Assess pancreatic graft function
Time frame: 1 year
Assess pancreatic graft function
Time frame: 1 year
Assess pancreatic graft function
Time frame: 1 year
Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation)
Time frame: 1 year
Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation)
Time frame: 1 year
Assess renal graft function (in the case of simultaneous kidney-pancreas transplantation)
Time frame: 1 year
Assess the occurrence of severe bacterial infections
Time frame: up to 1 year
Assess the occurrence of Cytomégalovirus infection
Time frame: up to 1 year
Assess the occurrence of BK virus infection
Time frame: up to 1 year
Assess the occurrence of fungal infection
Time frame: up to 1 year
Assess the occurrence of pancreatic graft rejection
Time frame: up to 1 year
Assess the occurrence of renal graft rejection (in the case of simultaneous kidney-pancreas transplantation)
Time frame: up to 1 year
Assess the occurrence of graft-specific antibodies
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anakinra 100Mg/0.67Ml Inj Syringe in people with Pancreatic Transplant, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe MASSET (2.76.64.39.61 ext. +33, christophe.masset@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the safety of IL-1β in a pilot study of patients who have undergone a pancreas transplant (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.