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Monoclonal Antibodies

Etanercept for Kidney Failure After Lung Transplant

Q: Is this trial accepting new participants at the present time?

<p>According to clinicaltrials.gov, this particualr study published on August 15th 2023 and last modified on July 10th is no longer recruiting patients; however, there are a plethora of other medical trials that still require volunteers at the present time.</p>

Q: What core aims are being pursued through this investigation?

<p>In this medical study, the primary outcome measure is kidney dysfunction within one to seven days after a lung <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a>. Secondary outcomes include intensive care unit (ICU) stay duration measured by the number of ICU post-transplant days, ventilator use time defined as number of days on a ventilator following the transplantation procedure, and patient survival status at any given point in time.</p>

Phase < 1

Waitlist Available

Led By Chitaru Kurihara, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planning to undergo transplantation of the lung at Northwestern Memorial Hospital.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial looks at whether a drug can protect kidneys after lung transplants and improve outcomes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Etanercept may cause side effects like infections, allergic reactions, skin issues, heart failure exacerbation in some patients, and possible autoimmune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of kidney dysfunction immediately after lung transplant

Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant

Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant

Secondary outcome measures

Length of intensive care unit (ICU) stay

Length of ventilator use

Occurrence of primary graft dysfunction

+1 more

Side effects data

From 2015 Phase 4 trial • 491 Patients • NCT01578850

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Open-Label Treatment

Etanercept

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EtanerceptExperimental Treatment1 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: ControlActive Control1 Intervention

Participants receive standard lung transplant care.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,211 Total Patients Enrolled

Chitaru Kurihara, MDPrincipal InvestigatorNorthwestern University

Media Library

Etanercept (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05950724 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accepting new participants at the present time?

"According to clinicaltrials.gov, this particualr study published on August 15th 2023 and last modified on July 10th is no longer recruiting patients; however, there are a plethora of other medical trials that still require volunteers at the present time."

Answered by AI

What core aims are being pursued through this investigation?

"In this medical study, the primary outcome measure is kidney dysfunction within one to seven days after a lung transplant. Secondary outcomes include intensive care unit (ICU) stay duration measured by the number of ICU post-transplant days, ventilator use time defined as number of days on a ventilator following the transplantation procedure, and patient survival status at any given point in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Chitaru Kurihara 2023. "RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950724.