Anakinra for Lung Transplant Recipients
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Chitaru Kurihara, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who are about to receive a lung transplant and can give informed consent. They must be undergoing a special procedure called ex vivo lung perfusion (EVLP) before the transplant.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of Anakinra injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant
Post-operative Monitoring
Participants are monitored for primary graft dysfunction and other outcomes post lung transplant
Follow-up
Participants are monitored for safety and effectiveness, including ICU stay, hospital stay, ventilator use, and survival status
What Are the Treatments Tested in This Trial?
Interventions
- Anakinra
Trial Overview
The study is testing if Anakinra, injected into the solution where donor lungs are stored before transplant, can prevent primary graft dysfunction—low oxygen levels and inflammation in the lungs after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
One dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant.
Control group will not receive Anakinra during EVLP.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
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