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NCT Number: NCT07410312

BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location contact

Chitaru Kurihara, MD

PRINCIPAL_INVESTIGATOR

Mary Carns, MS

CONTACT

[email protected]

312-503-1137

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Anakinra

Drug

100 mg injection

Primary outcomes

  1. Primary graft dysfunction after lung transplant

    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.

Secondary outcomes

  1. Length of ICU stay post lung transplant, assessed up to one year post transplant

    Time frame: Days post lung transplant up to 52 weeks

    Length of intensive care unit stay post lung transplant

  2. Length of hospital stay post lung transplant, assessed up to one year post transplant

    Time frame: Days post lung transplant up to 52 weeks

    Length of hospital stay post lung transplant

  3. Length of ventilator use post lung transplant, assessed up to one year post transplant

    Time frame: Days post lung transplant up to 52 weeks

    Length of ventilator use post lung transplant

  4. Survival after 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Carns, MS

CONTACT

[email protected]

312-503-1137

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Jun 25, 2026

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.

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