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 — DRUG
    100 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 EVLP
    One dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant.
  • No Intervention: Control group
    Control 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

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Mary Carns, MS
312-503-1137
Chitaru Kurihara, MD (PRINCIPAL_INVESTIGATOR)

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