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

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

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.