Northwestern University
Chicago, Illinois, 60611, United States
NCT Number: NCT07410312
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Early Phase 1
Chicago, Illinois, 60611, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100 mg injection
Time frame: 3 days post 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: Days post lung transplant up to 52 weeks
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
Time frame: Days post lung transplant up to 52 weeks
Length of ventilator use post lung transplant
Time frame: 30 days, 90 days and one year post lung transplant
30 days, 90 days, and one year survival status after lung transplant
Contact information is provided by the study sponsor or research team.
Northwestern University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07120230
Lung Transplant Recipient
Guangzhou, Guangdong, China
View Trial DetailsNCT07235683
CMV, Lung Transplant Recipient
Toronto, Ontario, Canada
View Trial DetailsNCT07189377
Blood-Borne Infections, Communicable Diseases
Toronto, Ontario, Canada
View Trial Details