NCT07410312

BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Lung Transplant Recipient

Interventions

Type	Name	Description
DRUG	Anakinra	100 mg injection

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study