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

NCT07410312 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STU00223759
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Transplant Recipient

Keywords

lung transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Days post lung transplant up to 52 weeks

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

  Days post lung transplant up to 52 weeks

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

  Days post lung transplant up to 52 weeks

• Survival after lung transplant

  30 days, 90 days and one year post lung transplant

Study Arms (2)

Treatment group: Anakinra during EVLP

EXPERIMENTAL

One dose (100mg) Anakinra will be injected into the perfusion solution during ex vivo lung perfusion (EVLP) prior to lung transplant.

Drug: Anakinra

Control group

NO INTERVENTION

Control group will not receive Anakinra during EVLP.

Interventions

Anakinra DRUG

100 mg injection

Treatment group: Anakinra during EVLP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Chitaru Kurihara, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Carns, MS

CONTACT

312-503-1137; m-carns@northwestern.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)