RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

NCT ID: NCT05950724

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-17

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to assess whether TNFa antibody use before lung transplant can prevent kidney injury after lung transplant.

Detailed Description

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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 receive one dose of the study drug, Etanercept, via subcutaneous injection just prior to the lung transplant. Patients randomized to the control group will not receive Etanercept. Both groups will receive standard lung transplant care after implantation.

Conditions

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Lung Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Etanercept

Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care.

Group Type EXPERIMENTAL

Etanercept Injection [Enbrel]

Intervention Type DRUG

25 mg subcutaneous injection

Control

Participants receive standard lung transplant care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Etanercept Injection [Enbrel]

25 mg subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Planning to undergo transplantation of the lung at Northwestern Memorial Hospital.
* Willing and able to read, understand, and be capable of giving informed consent.

Exclusion Criteria

* Previous or current use of TNFa antibody.
* Positive virtual or retrospective crossmatch or highly sensitized (pRA \> 30%) recipients.
* Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Chitaru Kurihara

Instructor of Surgery, Feinberg School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chitaru Kurihara, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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STU00218926

Identifier Type: -

Identifier Source: org_study_id

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