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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Transplant Recipient
• Intervention / Treatment: Drug: Anakinra

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mary Carns, MS; Phone Number: 312-503-1137; Email: m-carns@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
      • Contact: Mary Carns, MS; Phone Number: 312-503-1137; Email: m-carns@northwestern.edu
      • Principal Investigator: Chitaru Kurihara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group: Anakinra during EVLP; One dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant.	Drug: Anakinra; 100 mg injection
No Intervention: Control group; Control group will not receive Anakinra during EVLP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary graft dysfunction after 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.	3 days post lung transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay post lung transplant, assessed up to one year post transplant	Length of intensive care unit stay post lung transplant	Days post lung transplant up to 52 weeks
Length of hospital stay post lung transplant, assessed up to one year post transplant	Length of hospital stay post lung transplant	Days post lung transplant up to 52 weeks
Length of ventilator use post lung transplant, assessed up to one year post transplant	Length of ventilator use post lung transplant	Days post lung transplant up to 52 weeks
Survival after lung transplant	30 days, 90 days, and one year survival status after lung transplant	30 days, 90 days and one year post lung transplant

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Chitaru Kurihara, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 27, 2025
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: lung transplant
• Additional Relevant MeSH Terms: Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Intercellular Signaling Peptides and Proteins; Cytokines; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: STU00223759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes