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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Etanercept, a TNF receptor fusion protein, can prevent kidney problems in lung transplant recipients. Etanercept is administered as a single injection before the transplant. Individuals planning their lung transplant at Northwestern Memorial Hospital who can understand and agree to the trial terms may qualify. Participants will receive either Etanercept or standard lung transplant care. As an Early Phase 1 trial, this research focuses on understanding Etanercept's effects in humans, offering participants a chance to contribute to groundbreaking medical research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Etanercept is likely to be safe for humans?

Research shows that etanercept, a treatment that blocks the protein TNF-alpha, is being tested to prevent kidney problems after a lung transplant. Previous studies have examined its safety in various medical contexts.

The FDA has already approved etanercept for other conditions, such as rheumatoid arthritis, indicating general safety. However, this trial is in an early stage, known as Early Phase 1, meaning limited safety information exists for lung transplant recipients.

Early trials typically focus on how well participants tolerate the treatment and identify potential side effects. Although etanercept has been used safely in other contexts, its effectiveness in preventing kidney issues post-transplant remains under investigation. Researchers will closely monitor participants for any adverse effects during the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for kidney failure after lung transplant, which mainly involves supportive treatments like dialysis and medications to manage symptoms, Etanercept offers a new approach by targeting specific inflammatory pathways. Etanercept is a biologic that blocks tumor necrosis factor (TNF), a substance in the body that contributes to inflammation and can damage kidney function. Researchers are excited about Etanercept because it could potentially reduce inflammation more effectively and prevent kidney damage, offering a proactive solution rather than just managing symptoms. Additionally, the delivery method via subcutaneous injection before surgery is convenient and could integrate seamlessly with existing transplant procedures.

What evidence suggests that Etanercept might be an effective treatment for kidney failure after lung transplant?

Research has shown that etanercept, a medication that blocks a protein called TNF-alpha, might help prevent kidney problems. In this trial, some participants will receive etanercept, while others will receive standard lung transplant care. Studies on similar treatments have found that blocking TNF-alpha can improve kidney health without affecting transplanted organs. Specifically, etanercept reduced kidney damage and improved kidney structure in certain conditions. Additionally, treatments that block TNF-alpha have successfully treated ongoing inflammation in kidney transplant patients. These findings suggest that etanercept might help protect kidneys after a lung transplant by reducing inflammation. ^{1 4 6 7 8}

Who Is on the Research Team?

Chitaru Kurihara, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/early-phase-1-lung-transplant-complications-7-2023-864fb

Etanercept for Kidney Failure After Lung Transplant 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02495077

Effects of Inhibiting Early Inflammation in Kidney Transplant ... The purpose of this study is to evaluate whether taking infliximab, which blocks tumor necrosis factor alpha (TNF-alpha), just prior to transplant surgery,

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5072954/

Anti-TNFα therapy for chronic inflammatory disease in ... Anti-TNFα therapies are effective for treating chronic inflammatory diseases in kidney transplant patients and do not lead to graft function deterioration.

4. medscidiscovery.com medscidiscovery.com/index.php/msd/article/view/1066

Etanercept in Acute Kidney Failure The results demonstrated that Etanercept improved kidney morphology damaged by folic acid, reduced the apoptotic index, and gradually decreased elevated blood ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2016/10110/anti_tnf__therapy_for_chronic_inflammatory_disease.31.aspx

Anti-TNFα therapy for chronic inflammatory disease in kidney Anti-TNFα therapies resulted in a clinical response in 13/16 patients (81%). Estimated glomerular filtration rates (MDRD-4) were similar on day 0 and at 24 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0049017221001670

Safety of biologic treatments in solid organ transplant ... This study aimed to evaluate complications occurring with biologic treatments in solid-organ transplant recipients.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3610695/

Monitoring of Nonsteroidal Immunosuppressive Drugs in ... For lung transplant recipients receiving CNI therapy who develop renal dysfunction, a reduction in the target dose concentration is suggested (Grade 2C). 3.3 ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817640

Anti–Tumor Necrosis Factor Therapy and Risk of Kidney ... In this cohort study of 10 689 US veterans with new-onset IBD, incident use of TNF inhibitors was independently associated with higher risk of progressive ...