Anakinra for Lung Transplant Recipients

Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

CK

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

I am 18 years old or older.
I will undergo a special lung preparation procedure before my transplant.
I am planning to have a lung transplant.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Anakinra injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant

Immediate pre-transplant
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for primary graft dysfunction and other outcomes post lung transplant

3 days
Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including ICU stay, hospital stay, ventilator use, and survival status

52 weeks

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

Group I: Treatment group: Anakinra during EVLPExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+