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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05950724
Recruitment Status : Enrolling by invitation
First Posted : July 18, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Chitaru Kurihara, Northwestern University

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

Condition or disease Intervention/treatment Phase
Lung Transplant; Complications Drug: Etanercept Injection [Enbrel] Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
Actual Study Start Date : September 17, 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arms and Interventions
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Arm Intervention/treatment
Experimental: Etanercept
Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care.
 Drug: Etanercept Injection [Enbrel]
25 mg subcutaneous injection
No Intervention: Control
Participants receive standard lung transplant care.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05950724


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Chitaru Kurihara, MD Northwestern University
More Information
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Publications:

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Responsible Party: Chitaru Kurihara, Instructor of Surgery, Feinberg School of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT05950724    
Other Study ID Numbers: STU00218926
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Renal Insufficiency
Primary Graft Dysfunction
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
 Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors