What this study is
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.
What's being tested
- Anakinra
Intervention · DRUG
100 mg injection
Study details
- Sponsor
- Northwestern University
- Conditions
- Lung Transplant Recipient
- Enrolling
- 20 people
- Starts
- 2026-10-01
- Est. completion
- 2027-12
- Design
- Open-label, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNorthwestern University
Chicago, Illinois, United States
- Mary Carns, MS · Contact312-503-1137m-carns@northwestern.edu
- Chitaru Kurihara, MD · Principal investigator
Study team
Sponsor
Northwestern University
Study ID STU00223759
Principal investigator
Chitaru Kurihara, MD
Northwestern University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.