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

Study Overview
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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.

Official Title
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RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

Conditions
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Lung Transplant; Complications

Intervention / Treatment
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* Drug: Etanercept Injection [Enbrel]


Participation Criteria
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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. Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etanercept<br>Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care. | Drug: Etanercept Injection [Enbrel]<br>* 25 mg subcutaneous injection<br>|
| No Intervention: Control<br>Participants receive standard lung transplant care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of kidney dysfunction immediately after lung transplant | Measured by serum creatinine blood tests | Immediately after lung transplant | 
| Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant | Measured by serum creatinine blood tests | Within 1-7 days after lung transplant | 
| Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant | Measured by serum creatinine blood tests | Up to 30 days after lung transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of primary graft dysfunction | Measured by arterial blood gas (ABG) blood tests and chest X-rays | Within 3 days post-transplant | 
| Length of intensive care unit (ICU) stay | Measured by number of days in the ICU post-transplant | Through study completion, an average of 1 year | 
| Length of ventilator use | Measured by number of days on a ventilator post-transplant | Through study completion, an average of 1 year | 
| Survival | Alive or dead post-transplant | 30 days, 90 days, and one year survival post-transplant |