BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Northwestern University
- Study ID
- NCT07410312
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Lung Transplant Recipient
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Anakinra — DRUG100 mg injection
Study Details
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.
Key Dates
- Start date
- Feb 1, 2026
- Status verified
- Feb 2026
- Primary completion
- Aug 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment group: Anakinra during EVLPOne dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant.
- No Intervention: Control groupControl group will not receive Anakinra during EVLP.
Primary Outcome Measure
Primary graft dysfunction after lung transplant [ Time Frame: 3 days post lung transplant ]
Central Contacts
- Mary Carns, MS312-503-1137
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | Chitaru Kurihara, MD (PRINCIPAL_INVESTIGATOR) |