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

Sponsor
Northwestern University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05950724
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
19.5
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Occurrence of kidney dysfunction immediately after lung transplant [Immediately after lung transplant]

    Measured by serum creatinine blood tests

  2. Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant [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 [Up to 30 days after lung transplant]

    Measured by serum creatinine blood tests

Secondary Outcome Measures

  1. Occurrence of primary graft dysfunction [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 [Through study completion, an average of 1 year]

    Measured by number of days in the ICU post-transplant

  3. Length of ventilator use [Through study completion, an average of 1 year]

    Measured by number of days on a ventilator post-transplant

  4. Survival [30 days, 90 days, and one year survival post-transplant]

    Alive or dead post-transplant

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Chitaru Kurihara, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chitaru Kurihara, Instructor of Surgery, Feinberg School of Medicine, Northwestern University
ClinicalTrials.gov Identifier:
NCT05950724
Other Study ID Numbers:
  • STU00218926
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Renal Insufficiency
Primary Graft Dysfunction
Etanercept

Study Results

No Results Posted as of Jul 18, 2023