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

Primary Purpose

Lung Transplant; Complications

Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Etanercept Injection [Enbrel]
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Transplant; Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Etanercept

Control

Arm Description

Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care.

Participants receive standard lung transplant care.

Outcomes

Primary Outcome Measures

Occurrence of kidney dysfunction immediately after lung transplant
Measured by serum creatinine blood tests
Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant
Measured by serum creatinine blood tests
Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant
Measured by serum creatinine blood tests

Secondary Outcome Measures

Occurrence of primary graft dysfunction
Measured by arterial blood gas (ABG) blood tests and chest X-rays
Length of intensive care unit (ICU) stay
Measured by number of days in the ICU post-transplant
Length of ventilator use
Measured by number of days on a ventilator post-transplant
Survival
Alive or dead post-transplant

Full Information

First Posted
July 3, 2023
Last Updated
September 8, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05950724
Brief Title
RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
Official Title
RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant; Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Etanercept
Arm Type
Experimental
Arm Description
Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive standard lung transplant care.
Intervention Type
Drug
Intervention Name(s)
Etanercept Injection [Enbrel]
Intervention Description
25 mg subcutaneous injection
Primary Outcome Measure Information:
Title
Occurrence of kidney dysfunction immediately after lung transplant
Description
Measured by serum creatinine blood tests
Time Frame
Immediately after lung transplant
Title
Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant
Description
Measured by serum creatinine blood tests
Time Frame
Within 1-7 days after lung transplant
Title
Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant
Description
Measured by serum creatinine blood tests
Time Frame
Up to 30 days after lung transplant
Secondary Outcome Measure Information:
Title
Occurrence of primary graft dysfunction
Description
Measured by arterial blood gas (ABG) blood tests and chest X-rays
Time Frame
Within 3 days post-transplant
Title
Length of intensive care unit (ICU) stay
Description
Measured by number of days in the ICU post-transplant
Time Frame
Through study completion, an average of 1 year
Title
Length of ventilator use
Description
Measured by number of days on a ventilator post-transplant
Time Frame
Through study completion, an average of 1 year
Title
Survival
Description
Alive or dead post-transplant
Time Frame
30 days, 90 days, and one year survival post-transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chitaru Kurihara, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

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