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

NCT05950724 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: STU00218926
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Transplant; Complications

Outcome Measures

Primary Outcomes (3)

• Occurrence of kidney dysfunction immediately after lung transplant

  Measured by serum creatinine blood tests

  Immediately after lung transplant

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

  Measured by serum creatinine blood tests

  Within 1-7 days after lung transplant

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

  Measured by serum creatinine blood tests

  Up to 30 days after lung transplant

Secondary Outcomes (4)

• Occurrence of primary graft dysfunction

  Within 3 days post-transplant

• Length of intensive care unit (ICU) stay

  Through study completion, an average of 1 year

• Length of ventilator use

  Through study completion, an average of 1 year

• Survival

  30 days, 90 days, and one year survival post-transplant

Study Arms (2)

Etanercept

EXPERIMENTAL

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]

Control

NO INTERVENTION

Participants receive standard lung transplant care.

Interventions

Etanercept Injection [Enbrel] DRUG

25 mg subcutaneous injection

Etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planning to undergo transplantation of the lung at Northwestern Memorial Hospital.
• Willing and able to read, understand, and be capable of giving informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (15)

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MeSH Terms

Interventions

Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Chitaru Kurihara, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Surgery, Feinberg School of Medicine

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 18, 2023
• Study Start: September 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)