Etanercept for Kidney Failure After Lung Transplant

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: TNFa antibodies

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Chitaru Kurihara, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for individuals preparing for a lung transplant at Northwestern Memorial Hospital who can understand and consent to the study. It's not open to those with conditions that make participation too risky or anyone previously or currently treated with TNFa antibodies.

Inclusion Criteria

I can read and understand information and am capable of giving informed consent.

I am scheduled for a lung transplant at Northwestern Memorial Hospital.

Exclusion Criteria

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

I have used TNFa antibody in the past or am currently using it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of Etanercept via subcutaneous injection just prior to lung transplant

Immediate

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for kidney dysfunction and primary graft dysfunction after lung transplant

1 month

Multiple visits (in-person)

Follow-up

Participants are monitored for survival and long-term outcomes post-transplant

1 year

Treatment Details

Interventions

• Etanercept

Trial Overview The RENAL trial is testing if an injection of Etanercept (Enbrel), which blocks TNF-alpha, can prevent kidney problems after a lung transplant. The focus is on improving renal function and reducing primary graft dysfunction post-surgery.

Participant Groups

Group I: Etanercept Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

Participants receive standard lung transplant care.

Etanercept is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Enbrel for:

• Moderate to Severe Rheumatoid Arthritis
• Moderate to Severe Polyarticular Juvenile Rheumatoid Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Moderate to Severe Plaque Psoriasis

Approved in European Union as Enbrel for:

• Rheumatoid Arthritis
• Juvenile Idiopathic Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Plaque Psoriasis

Approved in Canada as Enbrel for:

• Rheumatoid Arthritis
• Juvenile Idiopathic Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Plaque Psoriasis

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+