An Early Phase 1 interventional study of Anakinra in Lung Transplant Recipient, sponsored by Northwestern University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Northwestern University · Early Phase 1, Interventional, and Treatment
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.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant.
Drug: Anakinra
Control group will not receive Anakinra during EVLP.
100 mg injection
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.
Time frame: 3 days post lung transplant
Length of ICU stay post lung transplant, assessed up to one year post transplant
Length of intensive care unit stay post lung 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
Length of hospital stay post lung 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
Length of ventilator use post lung transplant
Time frame: Days post lung transplant up to 52 weeks
Survival after lung transplant
30 days, 90 days, and one year survival status after lung transplant
Time frame: 30 days, 90 days and one year post lung transplant
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Northwestern University