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Enrolling by Invitation

NCT Number: NCT05950724

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

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

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Key information

Conditions

Lung Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Positive virtual or retrospective crossmatch or highly sensitized (pRA > 30%) recipients.
  • Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.

Treatment and study plan

Etanercept Injection [Enbrel]

Drug

25 mg subcutaneous injection

Primary outcomes

  1. Occurrence of kidney dysfunction immediately after lung transplant

    Time frame: Immediately after lung transplant

    Measured by serum creatinine blood tests

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

    Time frame: Within 1-7 days after lung transplant

    Measured by serum creatinine blood tests

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

    Time frame: Up to 30 days after lung transplant

    Measured by serum creatinine blood tests

Secondary outcomes

  1. Occurrence of primary graft dysfunction

    Time frame: Within 3 days post-transplant

    Measured by arterial blood gas (ABG) blood tests and chest X-rays

  2. Length of intensive care unit (ICU) stay

    Time frame: Through study completion, an average of 1 year

    Measured by number of days in the ICU post-transplant

  3. Length of ventilator use

    Time frame: Through study completion, an average of 1 year

    Measured by number of days on a ventilator post-transplant

  4. Survival

    Time frame: 30 days, 90 days, and one year survival post-transplant

    Alive or dead post-transplant

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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