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

Northwestern University

Status and phase: Invitation-only; Early Phase 1

Conditions: Lung Transplant; Complications

Treatments: Drug: Etanercept Injection [Enbrel]

Study type: Interventional

Funder types: Other

Identifiers

NCT05950724

STU00218926

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Etanercept

Experimental group

Description:

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

Treatment:

Drug: Etanercept Injection [Enbrel]

Control

No Intervention group

Description:

Participants receive standard lung transplant care.