RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
- Conditions
- Lung Transplant; Complications
- Interventions
- Registration Number
- NCT05950724
- Lead Sponsor
- Northwestern University
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- Planning to undergo transplantation of the lung at Northwestern Memorial Hospital.
- Willing and able to read, understand, and be capable of giving informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Etanercept Etanercept Injection [Enbrel] Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care.
- Primary Outcome Measures
Name Time Method Occurrence of kidney dysfunction immediately after lung transplant Immediately after lung transplant Measured by serum creatinine blood tests
Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant Up to 30 days after lung transplant Measured by serum creatinine blood tests
Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant Within 1-7 days after lung transplant Measured by serum creatinine blood tests
- Secondary Outcome Measures
Name Time Method Length of intensive care unit (ICU) stay Through study completion, an average of 1 year Measured by number of days in the ICU post-transplant
Occurrence of primary graft dysfunction Within 3 days post-transplant Measured by arterial blood gas (ABG) blood tests and chest X-rays
Length of ventilator use Through study completion, an average of 1 year Measured by number of days on a ventilator post-transplant
Survival 30 days, 90 days, and one year survival post-transplant Alive or dead post-transplant
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States