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

RENAL: Randomized Clinical Trial of 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Transplant; Complications
• Intervention / Treatment: Drug: Etanercept Injection [Enbrel]

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of primary graft dysfunction	Measured by arterial blood gas (ABG) blood tests and chest X-rays	Within 3 days post-transplant
Length of intensive care unit (ICU) stay	Measured by number of days in the ICU post-transplant	Through study completion, an average of 1 year
Length of ventilator use	Measured by number of days on a ventilator post-transplant	Through study completion, an average of 1 year
Survival	Alive or dead post-transplant	30 days, 90 days, and one year survival post-transplant

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Chitaru Kurihara, MD, Northwestern University

Publications and helpful links

General Publications

• Meroni PL, Valentini G, Ayala F, Cattaneo A, Valesini G. New strategies to address the pharmacodynamics and pharmacokinetics of tumor necrosis factor (TNF) inhibitors: A systematic analysis. Autoimmun Rev. 2015 Sep;14(9):812-29. doi: 10.1016/j.autrev.2015.05.001. Epub 2015 May 15.
• Wajda-Pokrontka M, Nadziakiewicz P, Krauchuk A, Ochman M, Zawadzki F, Przybylowski P. Influence of Fluid Therapy on Kidney Function in the Early Postoperative Period After Lung Transplantation. Transplant Proc. 2022 May;54(4):1115-1119. doi: 10.1016/j.transproceed.2022.02.021. Epub 2022 Apr 13.
• Komaki Y, Yamada A, Komaki F, Kudaravalli P, Micic D, Ido A, Sakuraba A. Efficacy, safety and pharmacokinetics of biosimilars of anti-tumor necrosis factor-alpha agents in rheumatic diseases; A systematic review and meta-analysis. J Autoimmun. 2017 May;79:4-16. doi: 10.1016/j.jaut.2017.02.003. Epub 2017 Feb 13.
• Rubbert-Roth A, Atzeni F, Masala IF, Caporali R, Montecucco C, Sarzi-Puttini P. TNF inhibitors in rheumatoid arthritis and spondyloarthritis: Are they the same? Autoimmun Rev. 2018 Jan;17(1):24-28. doi: 10.1016/j.autrev.2017.11.005. Epub 2017 Nov 3.
• Haraoui B. Differentiating the efficacy of the tumor necrosis factor inhibitors. Semin Arthritis Rheum. 2005 Apr;34(5 Suppl1):7-11. doi: 10.1016/j.semarthrit.2005.01.003.
• Gottlieb AB. Tumor necrosis factor blockade: mechanism of action. J Investig Dermatol Symp Proc. 2007 May;12(1):1-4. doi: 10.1038/sj.jidsymp.5650029.
• Roach DR, Bean AG, Demangel C, France MP, Briscoe H, Britton WJ. TNF regulates chemokine induction essential for cell recruitment, granuloma formation, and clearance of mycobacterial infection. J Immunol. 2002 May 1;168(9):4620-7. doi: 10.4049/jimmunol.168.9.4620.
• Mocci G, Marzo M, Papa A, Armuzzi A, Guidi L. Dermatological adverse reactions during anti-TNF treatments: focus on inflammatory bowel disease. J Crohns Colitis. 2013 Nov;7(10):769-79. doi: 10.1016/j.crohns.2013.01.009. Epub 2013 Mar 1.
• Grivennikov SI, Tumanov AV, Liepinsh DJ, Kruglov AA, Marakusha BI, Shakhov AN, Murakami T, Drutskaya LN, Forster I, Clausen BE, Tessarollo L, Ryffel B, Kuprash DV, Nedospasov SA. Distinct and nonredundant in vivo functions of TNF produced by t cells and macrophages/neutrophils: protective and deleterious effects. Immunity. 2005 Jan;22(1):93-104. doi: 10.1016/j.immuni.2004.11.016.
• Arnold CM, Bailey DA, Faulkner RA, McKay HA, McCulloch RG. The effect of water fluoridation on the bone mineral density of young women. Can J Public Health. 1997 Nov-Dec;88(6):388-91. doi: 10.1007/BF03403912.
• Gerriets V, Goyal A, Khaddour K. Tumor Necrosis Factor Inhibitors. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482425/
• Carcinoma of hypopharynx and cervical oesophagus. Br Med J. 1967 Jun 17;2(5554):718. doi: 10.1136/bmj.2.5554.718. No abstract available.
• Tsuhako S. [Beginning course of English medical terminology based on analytical method]. Sogo Kango. 1994 May;29(2):91-4. No abstract available. Japanese.
• Puffer LB Jr. Legal problems of the intensive care unit. Med Clin North Am. 1971 Sep;55(5):1365-74. doi: 10.1016/s0025-7125(16)32473-7. No abstract available.
• Horn SD. Overview of current models for prospective payment. ANA Publ. 1984 Apr;(G-164):24-35. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Postoperative Complications; Reperfusion Injury; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Primary Graft Dysfunction; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Receptors, Cell Surface; Membrane Proteins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Etanercept
• Other Study ID Numbers: STU00218926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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