Lung Transplant; ComplicationsEarly Phase 1NCT05950724
RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
A Early Phase 1 study testing Etanercept Injection [Enbrel] in people with Lung Transplant; Complications, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to assess whether TNFa antibody use before lung transplant can prevent kidney injury after lung transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- Etanercept Injection [Enbrel]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2023to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning to undergo transplantation of the lung at Northwestern Memorial Hospital.
- Willing and able to read, understand, and be capable of giving informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Transplant; Complications
- Being tested
- Etanercept Injection [Enbrel]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etanercept Injection [Enbrel]Drug
25 mg subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care. Receives: Drug: Etanercept Injection [Enbrel] |
| Control | No intervention | Participants receive standard lung transplant care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of kidney dysfunction immediately after lung transplant
Measured by serum creatinine blood tests
Measured: Immediately after lung transplant
Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant
Measured by serum creatinine blood tests
Measured: 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
Measured: Up to 30 days after lung transplant
Secondary outcomes (4)
Occurrence of primary graft dysfunction
Measured by arterial blood gas (ABG) blood tests and chest X-rays
Measured: Within 3 days post-transplant
Length of intensive care unit (ICU) stay
Measured by number of days in the ICU post-transplant
Measured: Through study completion, an average of 1 year
Length of ventilator use
Measured by number of days on a ventilator post-transplant
Measured: Through study completion, an average of 1 year
Survival
Alive or dead post-transplant
Measured: 30 days, 90 days, and one year survival post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start17 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chitaru Kurihara, Northwestern University
- Investigators
- Chitaru Kurihara, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950724
- Sponsor's protocol ID
- STU00218926
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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/s40620-022-01392-z. Epub 2022 Jul 15.
PubMed 35838909Wajda-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.
PubMed 35428509Gerriets 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/
PubMed 29494032Meroni 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.
PubMed 25985765Komaki 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.
PubMed 28209290Rubbert-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.
PubMed 29108829Haraoui 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.
PubMed 15852248Gottlieb 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.
PubMed 17502861Roach 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.
PubMed 11971010Mocci 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.
PubMed 23453887Hsiao HM, Fernandez R, Tanaka S, Li W, Spahn JH, Chiu S, Akbarpour M, Ruiz-Perez D, Wu Q, Turam C, Scozzi D, Takahashi T, Luehmann HP, Puri V, Budinger GRS, Krupnick AS, Misharin AV, Lavine KJ, Liu Y, Gelman AE, Bharat A, Kreisel D. Spleen-derived classical monocytes mediate lung ischemia-reperfusion injury through IL-1beta. J Clin Invest. 2018 Jul 2;128(7):2833-2847. doi: 10.1172/JCI98436. Epub 2018 May 21.
PubMed 29781811Kurihara C, Lecuona E, Wu Q, Yang W, Nunez-Santana FL, Akbarpour M, Liu X, Ren Z, Li W, Querrey M, Ravi S, Anderson ML, Cerier E, Sun H, Kelly ME, Abdala-Valencia H, Shilatifard A, Mohanakumar T, Budinger GRS, Kreisel D, Bharat A. Crosstalk between nonclassical monocytes and alveolar macrophages mediates transplant ischemia-reperfusion injury through classical monocyte recruitment. JCI Insight. 2021 Mar 22;6(6):e147282. doi: 10.1172/jci.insight.147282.
PubMed 33621212Zheng Z, Chiu S, Akbarpour M, Sun H, Reyfman PA, Anekalla KR, Abdala-Valencia H, Edgren D, Li W, Kreisel D, Korobova FV, Fernandez R, McQuattie-Pimentel A, Zhang ZJ, Perlman H, Misharin AV, Scott Budinger GR, Bharat A. Donor pulmonary intravascular nonclassical monocytes recruit recipient neutrophils and mediate primary lung allograft dysfunction. Sci Transl Med. 2017 Jun 14;9(394):eaal4508. doi: 10.1126/scitranslmed.aal4508.
PubMed 28615357Heung LJ, Hohl TM. Inflammatory monocytes are detrimental to the host immune response during acute infection with Cryptococcus neoformans. PLoS Pathog. 2019 Mar 21;15(3):e1007627. doi: 10.1371/journal.ppat.1007627. eCollection 2019 Mar.
PubMed 30897162Grivennikov 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.
PubMed 15664162
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant
- ClinicalTrials.gov ID
- NCT05950724
- Acronym / sponsor ID
- STU00218926
- Conditions
- Lung Transplant; Complications
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 17 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: Etanercept Injection [Enbrel]Participants receive one dose (25mg) Etanercept via subcutaneous injection just prior to lung transplant. Following transplant, participants receive standard lung transplant care. |
| Control | No intervention | –Participants receive standard lung transplant care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planning to undergo transplantation of the lung at Northwestern Memorial Hospital.
- Willing and able to read, understand, and be capable of giving informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etanercept Injection [Enbrel]25 mg subcutaneous injection | Drug | Etanercept |
Primary outcome
Occurrence of kidney dysfunction immediately after lung transplant
Time frame: Immediately after lung transplant
Measured by serum creatinine blood tests
Occurrence of kidney dysfunction post-operatively within 1 week after lung transplant
Time frame: Within 1-7 days after lung transplant
Measured by serum creatinine blood tests
Occurrence of kidney dysfunction post-operatively within 1 month after lung transplant
Time frame: Up to 30 days after lung transplant
Measured by serum creatinine blood tests
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 35838909Scaravilli 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/s40620-022-01392-z. Epub 2022 Jul 15.
- Background: PubMed 35428509Wajda-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.
- Background: PubMed 29494032Gerriets 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/
- Background: PubMed 25985765Meroni 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.
- Background: PubMed 28209290Komaki 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.
- Background: PubMed 29108829Rubbert-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.
- Background: PubMed 15852248Haraoui 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.
- Background: PubMed 17502861Gottlieb 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.
- Background: PubMed 11971010Roach 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.
- Background: PubMed 23453887Mocci 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.
- Background: PubMed 29781811Hsiao HM, Fernandez R, Tanaka S, Li W, Spahn JH, Chiu S, Akbarpour M, Ruiz-Perez D, Wu Q, Turam C, Scozzi D, Takahashi T, Luehmann HP, Puri V, Budinger GRS, Krupnick AS, Misharin AV, Lavine KJ, Liu Y, Gelman AE, Bharat A, Kreisel D. Spleen-derived classical monocytes mediate lung ischemia-reperfusion injury through IL-1beta. J Clin Invest. 2018 Jul 2;128(7):2833-2847. doi: 10.1172/JCI98436. Epub 2018 May 21.
- Background: PubMed 33621212Kurihara C, Lecuona E, Wu Q, Yang W, Nunez-Santana FL, Akbarpour M, Liu X, Ren Z, Li W, Querrey M, Ravi S, Anderson ML, Cerier E, Sun H, Kelly ME, Abdala-Valencia H, Shilatifard A, Mohanakumar T, Budinger GRS, Kreisel D, Bharat A. Crosstalk between nonclassical monocytes and alveolar macrophages mediates transplant ischemia-reperfusion injury through classical monocyte recruitment. JCI Insight. 2021 Mar 22;6(6):e147282. doi: 10.1172/jci.insight.147282.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chitaru Kurihara, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Etanercept Injection [Enbrel] in people with Lung Transplant; Complications, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of kidney dysfunction immediately after lung transplant (time frame: Immediately after lung transplant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05950724, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.