Clinical trial NCT05950724: RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
Official title: RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Lung Transplant; Complications
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of kidney dysfunction immediately after lung transplant
timeFrame: Immediately after lung transplant
measure: Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant
timeFrame: Within 1-7 days after lung transplant
measure: Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant
timeFrame: Up to 30 days after lung transplant
Secondary outcomes:
measure: Occurrence of primary graft dysfunction
timeFrame: Within 3 days post-transplant
measure: Length of intensive care unit (ICU) stay
timeFrame: Through study completion, an average of 1 year
measure: Length of ventilator use
timeFrame: Through study completion, an average of 1 year
measure: Survival
timeFrame: 30 days, 90 days, and one year survival post-transplant
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Chitaru Kurihara, MD
role: PRINCIPAL_INVESTIGATOR
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