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Enrolling by invitation NCT05950724

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

Early Phase I Interventional Lung Transplant; Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Etanercept Injection [Enbrel].
Who it may be relevant to
Registry conditions: Lung Transplant; Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Etanercept Injection [Enbrel]
    25 mg subcutaneous injection

Primary outcome measures

  • Occurrence of kidney dysfunction immediately after lung transplant [Time frame: Immediately after lung transplant]
  • Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant [Time frame: Within 1-7 days after lung transplant]
  • Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant [Time frame: Up to 30 days after lung transplant]
Secondary outcome measures (4)
  • Occurrence of primary graft dysfunction [Time frame: Within 3 days post-transplant]
  • Length of intensive care unit (ICU) stay [Time frame: Through study completion, an average of 1 year]
  • Length of ventilator use [Time frame: Through study completion, an average of 1 year]
  • Survival [Time frame: 30 days, 90 days, and one year survival post-transplant]

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Northwestern University — Chicago

Publications

  • Scaravilli V, Merrino A, Bichi F, Madotto F, Morlacchi LC, Nosotti M, Lissoni A, Rosso L, Blasi F, Pesenti A, Zanella A, Castellano G, Grasselli G. Longitudinal assessment of renal function after lung transplantation for cystic fibrosis: transition from post-operative acute kidney injury to acute kidney disease and chronic kidney failure. J Nephrol. 2022 Sep;35(7):1885-1893. doi: 10.1007/s40620-02 PMID 35838909
  • 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. PMID 35428509
  • Gerriets V, Goyal A, Khaddour K. Tumor Necrosis Factor Inhibitors. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482425/ PMID 29494032
  • 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. PMID 25985765
  • 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. PMID 28209290
  • 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. PMID 29108829
  • 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. PMID 15852248
  • 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. PMID 17502861

Identifiers

NCT: NCT05950724 · STU00218926

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗