Lung Transplant RecipientEarly Phase 1NCT07410312
BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction
A Early Phase 1 study testing Anakinra in people with Lung Transplant Recipient, run by Northwestern University at 1 site in United States.
Trial summary
This study will determine if primary graft dysfunction (which causes low blood oxygen levels and fluid or inflammation in the lungs) after lung transplant can be prevented through the use of the study drug (IL-1 receptor antagonist, Anakinra). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Recipient
- What is being tested?
- Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Dec 2027
- Phase
- Early Phase 1
- 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
- Age 18 years or older.
- Planning to undergo transplantation of the lung.
- Willing and able to read, understand, and be capable of giving informed consent.
- Use of ex vivo lung perfusion (EVLP) prior to lung transplant.
Who cannot join
- Previous or current use of IL-1R antagonist drug.
- Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating, such as highly sensitized patients who require additional immunosuppression, multiorgan transplant, and re- transplant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University
Chicago, Illinois, 60611
Mary Carns, MS, 312-503-1137, m-carns@northwestern.edu
Chitaru Kurihara, MD
About this study
This study will determine if primary graft dysfunction (which causes low blood oxygen levels and fluid or inflammation in the lungs) after lung transplant can be prevented through the use of the study drug (IL-1 receptor antagonist, Anakinra). In this study, lung transplant participants who are randomized to the treatment group will have the study drug injected into the solution that their donor lungs are kept in prior to transplant.
Read the detailed description
After being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. Patients randomized to the treatment group will have one dose of the study drug, Anakinra, injected into the perfusion solution that their donor lungs are kept in just prior to lung transplant. Both groups will receive standard lung transplant care after implantation.
- Conditions
- Lung Transplant Recipient
- Being tested
- Anakinra
- Keywords
- lung transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
100 mg injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group: Anakinra during EVLP | Experimental | One dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant. Receives: Drug: Anakinra |
| Control group | No intervention | Control group will not receive Anakinra during EVLP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary graft dysfunction after lung transplant
Occurrence of primary graft dysfunction after lung transplant on post-operative day 3, measured by arterial blood gas blood tests and chest X-rays.
Measured: 3 days post lung transplant
Secondary outcomes (4)
Length of ICU stay post lung transplant, assessed up to one year post transplant
Length of intensive care unit stay post lung transplant
Measured: Days post lung transplant up to 52 weeks
Length of hospital stay post lung transplant, assessed up to one year post transplant
Length of hospital stay post lung transplant
Measured: Days post lung transplant up to 52 weeks
Length of ventilator use post lung transplant, assessed up to one year post transplant
Length of ventilator use post lung transplant
Measured: Days post lung transplant up to 52 weeks
Survival after lung transplant
30 days, 90 days, and one year survival status after lung transplant
Measured: 30 days, 90 days and one year post lung transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RecipientStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chitaru Kurihara, Northwestern University
- Investigators
- Chitaru Kurihara, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410312
- Sponsor's protocol ID
- STU00223759
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction
- ClinicalTrials.gov ID
- NCT07410312
- Acronym / sponsor ID
- STU00223759
- Conditions
- Lung Transplant Recipient
- Keywords
- lung transplant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Feb 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.
This study will determine if primary graft dysfunction (which causes low blood oxygen levels and fluid or inflammation in the lungs) after lung transplant can be prevented through the use of the study drug (IL-1 receptor antagonist, Anakinra). In this study, lung transplant participants who are randomized to the treatment group will have the study drug injected into the solution that their donor lungs are kept in prior to transplant.
Detailed description
After being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. Patients randomized to the treatment group will have one dose of the study drug, Anakinra, injected into the perfusion solution that their donor lungs are kept in just prior to lung transplant. Both groups will receive standard lung transplant care after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group: Anakinra during EVLP | Experimental | Drug: AnakinraOne dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant. |
| Control group | No intervention | –Control group will not receive Anakinra during EVLP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Planning to undergo transplantation of the lung.
- Willing and able to read, understand, and be capable of giving informed consent.
- Use of ex vivo lung perfusion (EVLP) prior to lung transplant.
Key exclusion criteria (2 listed)
- Previous or current use of IL-1R antagonist drug.
- Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating, such as highly sensitized patients who require additional immunosuppression, multiorgan transplant, and re- transplant.
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 |
|---|---|---|
| Anakinra100 mg injection | Drug | Treatment group: Anakinra during EVLP |
Primary outcome
Primary graft dysfunction after lung transplant
Time frame: 3 days post lung transplant
Occurrence of primary graft dysfunction after lung transplant on post-operative day 3, measured by arterial blood gas blood tests and chest X-rays.
4 secondary outcomes
Length of ICU stay post lung transplant, assessed up to one year post transplant
Time frame: Days post lung transplant up to 52 weeks
Length of hospital stay post lung transplant, assessed up to one year post transplant
Time frame: Days post lung transplant up to 52 weeks
Length of ventilator use post lung transplant, assessed up to one year post transplant
Time frame: Days post lung transplant up to 52 weeks
Survival after lung transplant
Time frame: 30 days, 90 days and one year post lung transplant
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 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Chitaru Kurihara, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Anakinra in people with Lung Transplant Recipient, run by Northwestern University at 1 site in United States.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Mary Carns, MS (312-503-1137, m-carns@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary graft dysfunction after lung transplant (time frame: 3 days post lung transplant). 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 21 Aug 2026.