RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
NCT ID: NCT05950724
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
EARLY_PHASE1
20 participants
INTERVENTIONAL
2023-09-17
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Etanercept
Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care.
Etanercept Injection [Enbrel]
25 mg subcutaneous injection
Control
Participants receive standard lung transplant care.
No interventions assigned to this group
Interventions
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Etanercept Injection [Enbrel]
25 mg subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Willing and able to read, understand, and be capable of giving informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Chitaru Kurihara
Instructor of Surgery, Feinberg School of Medicine
Principal Investigators
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Chitaru Kurihara, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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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.
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.
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/
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.
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.
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.
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.
Other Identifiers
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STU00218926
Identifier Type: -
Identifier Source: org_study_id
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