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 trial aims to determine if the drug Anakinra can prevent primary graft dysfunction in lung transplant recipients. Primary graft dysfunction causes low oxygen levels and fluid or inflammation in the lungs post-transplant. In the treatment group, Anakinra will be added to the solution that maintains donor lung health before the transplant. The trial seeks participants planning a lung transplant using a technique called ex vivo lung perfusion (EVLP). As an Early Phase 1 trial, this research focuses on understanding how Anakinra works in people, offering participants an opportunity to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Anakinra is likely to be safe for humans?

Research has shown that Anakinra, the treatment being tested in this trial, is usually well-tolerated in other situations. The FDA has already approved Anakinra for treating conditions like rheumatoid arthritis, indicating its safety in those cases. However, since this trial is in its early stages, researchers are still studying Anakinra's safety specifically for lung transplants. Detailed information about side effects in this specific context is not yet available, but its testing suggests that early research supports its potential safety and effectiveness.12345

Why do researchers think this study treatment might be promising?

Most treatments for lung transplant patients focus on preventing organ rejection and managing infections with immunosuppressants and antibiotics. But Anakinra works differently, targeting inflammation by blocking a protein called interleukin-1 (IL-1), which plays a key role in inflammatory responses. Researchers are excited about Anakinra because it can be administered directly into the lung perfusion solution during ex vivo lung perfusion (EVLP), potentially reducing inflammation right before the transplant. This novel approach could lead to better transplant outcomes and improved lung function post-surgery.

What evidence suggests that Anakinra might be an effective treatment for primary graft dysfunction after lung transplant?

Research suggests that Anakinra might help reduce inflammation in lung transplant recipients. Anakinra blocks a protein called IL-1, which causes inflammation. In this trial, one group will receive Anakinra during ex vivo lung perfusion (EVLP) to assess its impact on donor lungs. Studies have shown that controlling IL-1 can improve the condition of donor lungs during EVLP, a process used to prepare lungs for transplant. This method has been linked to better outcomes in lung transplants. Although specific data on using Anakinra for this purpose is limited, its potential to reduce inflammation is promising.25678

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.
See 1 more

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+

Citations

Ex vivo lung perfusion: recent advancements and future ...

A radiographic score for human donor lungs on ex vivo lung perfusion predicts transplant outcomes. ... Safety and efficacy of ex vivo donor lung ...

Modeling the Effects of IL-1β-mediated Inflammation During...

The conversional efficacy of ex vivo lung perfusion and clinical outcomes in patients undergoing transplantation of donor lungs by ex vivo lung perfusion: a ...

Long-term outcomes of lung transplantation with ex vivo lung ...

Ex vivo lung perfusion (EVLP) has demonstrated encouraging short- and medium-term outcomes with limited data available on its long-term outcomes ...

Study Details | NCT03641677 | Increasing Lung Transplant ...

The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35316525/

Ex Vivo Lung Perfusion: A Review of Current and Future ...

Ex vivo lung perfusion (EVLP) is a modality that allows donor lungs to be evaluated in a closed circuit outside of the body and extends lung donor assessment.

Anakinra for Lung Transplant Recipients · Info for Participants

This Phase < 1 medical study run by Northwestern University needs participants to evaluate whether Anakinra will have tolerable side effects ...

Long-term outcomes of lung transplantation with ex vivo ...

Ex vivo lung perfusion (EVLP) has demonstrated encouraging short- and medium-term outcomes with limited data available on its long-term ...

Lung transplantation after ex vivo lung perfusion - PMC - NIH

EVLP was not associated with decreased short-term recipient survival or increased acute rejection compared with conventional transplant recipients.