Idiopathic Pulmonary FibrosisPhase 2NCT03562416
Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects
A Phase 2 study testing Nintedanib in people with Idiopathic Pulmonary Fibrosis and Lung Transplant; Complications, run by Temple University at 1 site in United States.
Trial summary
The aim of this study is to assess the utility of nintedanib therapy in addition to usual transplant care in single lung transplant recipients with idiopathic pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Lung Transplant; Complications
- What is being tested?
- Nintedanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 21 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 35-70.
- Lung transplantation listing diagnosis of pulmonary fibrosis
- Recipient of single lung transplantation within the past 60 days
Who cannot join
- History of intolerability to nintedanib (i.e. discontinued nintedanib in the pre-transplant period due to adverse drug effects)
- Liver transaminase elevation (AST or ALT > 1.5X the upper limit of normal)
- Total bilirubin > 1.5X the upper limit of normal
- Drugs that interfere with the metabolism or elimination of nintedanib or its metabolites - St. John's wort, carbamazepine, phenytoin, rifampin, dexamethasone, and others.
- Any history of bronchial anastomosis dehiscence or stenosis
- Bleeding risk, defined as any of the following:
Show all 9Show fewer
- Full-dose therapeutic anticoagulation (i.e. vitamin K antagonist, direct thrombin inhibitors, etc.)
- History of hemorrhagic central nervous system (CNS) event within 12 months of enrollment
- Coagulation parameters: international normalized ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 1.5X the upper limit of normal at enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Nintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled Trial
The aim of this study is to assess the utility of nintedanib therapy in addition to usual transplant care in single lung transplant recipients with idiopathic pulmonary fibrosis (IPF). The investigators hypothesize that in IPF subjects who undergo single lung transplantation the administration of nintedanib 150 mg twice daily in addition to usual transplant care will result in better preservation of lung function at 24 months.
Read the detailed description
Lung transplantation is the only treatment option that augments survival in patients with idiopathic pulmonary fibrosis (IPF). Despite several advancements in lung transplantation over the past three decades, long-term survival rates have remained low compared to other solid organ transplantations. The median survival after lung transplantation is only 5.8 years. Multiple factors account for the relatively low survival post-transplant, but chronic rejection resulting in obliterative bronchiolitis is a predominate cause. Further research is needed to develop medical therapeutic interventions that improve survival in IPF patients who undergo only single lung transplantation.
Nintedanib, a novel tyrosine kinase inhibitor, exhibits antifibrotic properties via multiple mechanisms including the inhibition of the receptor tyrosine kinases platelet derived growth factor (PDGF) receptor, fibroblast growth factor (FGF) receptor, and vascular endothelial growth factor (VEGF) receptor. Several mediators of pulmonary fibrosis including VEGF, FGF, and transforming growth factor beta (TGF-β) have also been implicated in the pathogenesis of bronchiolitis obliterans syndrome (BOS), the most common type of chronic lung allograft rejection.
Nintedanib is safe to continue until the time of lung transplantation and has not been shown to worsen perioperative outcomes in small case series, single center cohorts and our center's personal experience. The current practice in lung transplant medicine is to discontinue antifibrotic therapy after lung transplantation in IPF. In IPF patients who undergo single lung transplant, nintedanib therapy has the potential to preserve lung function in both the native fibrotic lung and the new lung allograft.
The investigators propose a randomized and placebo-controlled single center pilot trial comparing nintedanib therapy plus usual care to usual care only in IPF patients after single lung transplant. The investigators hypothesize that in IPF subjects who undergo single lung transplantation the administration of nintedanib 150 mg twice daily in addition to usual transplant care will result in better preservation of lung function at 24 months.
- Being tested
- Nintedanib, Placebo Oral Tablet
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Also called BIBF 1120, Ofev
Nintedanib (BIBF 1120, Ofev)
Placebo Oral TabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib | Experimental | Nintedanib 150 mg tablet by mouth twice daily for 24 months. Receives: Drug: Nintedanib |
| Placebo | Placebo comparator | Placebo tablet by mouth twice daily for 24 months Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1
Change in forced expiratory volume in 1 second (FEV1)
Measured: Baseline to 24 months
Change in FVC
Change in forced vital capacity (FVC)
Measured: Baseline to 24 months
Secondary outcomes (27)
Bronchiolitis obliterans syndrome
Incidence of bronchiolitis obliterans syndrome (BOS)
Measured: Baseline to 24 months
Bronchial stenosis
Incidence of surgical anastomosis bronchial stenosis
Measured: Baseline to 24 months
Bronchial dehiscence
Incidence of surgical anastomosis bronchial stenosis
Measured: Baseline to 24 months
Acute cellular rejection
Incidence of acute cellular rejection of lung allograft
Measured: Baseline to 24 months
Drug discontinuation
Study drug discontinuation rate due to adverse drug event
Measured: Baseline to 24 months
Adverse drug events
Incidence of adverse drug events (i.e. elevation of liver transaminases greater than 3 times the upper limit of normal, diarrhea, nausea, vomiting, anorexia, GERD)
Measured: Baseline to 24 months
Vascular endothelial growth factor (VEGF) - serum
Change in serum biomarker concentration for VEGF (pg/mL)
Measured: Baseline to day 30
Vascular endothelial growth factor (VEGF) - BAL
Change in BAL concentration for VEGF (pg/mL)
Measured: Baseline to day 30
Vascular endothelial growth factor (VEGF) - serum
Change in serum concentration for VEGF (pg/mL)
Measured: Baseline to day 300
Vascular endothelial growth factor (VEGF) - BAL
Change in BAL concentration for VEGF (pg/mL)
Measured: Baseline to day 300
Fibroblast growth factor (FGF) - serum
Change in serum concentration for FGF (pg/mL)
Measured: Baseline to day 30
Fibroblast growth factor (FGF) - BAL
Change in BAL concentration for FGF (pg/mL)
Measured: Baseline to day 30
Fibroblast growth factor (FGF) - serum
Change in serum concentration for FGF (pg/mL)
Measured: Baseline to day 300
Fibroblast growth factor (FGF) - BAL
Change in BAL biomarker concentration for FGF (pg/mL)
Measured: Baseline to day 300
Platelet derived growth factor (PDGF) - serum
Change in serum concentration for PDGF (pg/mL)
Measured: Baseline to day 30
Platelet derived growth factor (PDGF) - BAL
Change in BAL biomarker concentration for PDGF (pg/mL)
Measured: Baseline to day 30
Platelet derived growth factor (PDGF) - serum
Change in serum biomarker concentration for PDGF (pg/mL)
Measured: Baseline to day 300
Platelet derived growth factor (PDGF) - BAL
Change in BAL biomarker concentration for PDGF (pg/mL)
Measured: Baseline to day 300
Peripheral blood flow cytometry - CD4 T cells
CD4 T cell concentration in peripheral blood (cells/µL)
Measured: Day 30
Peripheral blood flow cytometry - CD4 T cells
CD4 T cell concentration in peripheral blood (cells/µL)
Measured: Day 300
Peripheral blood flow cytometry - CD8 T cells
CD8 T cell concentration in peripheral blood (cells/µL)
Measured: Day 30
Peripheral blood flow cytometry - CD8 T cells
CD8 T cell concentration in peripheral blood (cells/µL)
Measured: Day 300
Peripheral blood flow cytometry - macrophages
Macrophage concentration in peripheral blood (cells/µL)
Measured: Day 30
Peripheral blood flow cytometry - macrophages
Macrophage concentration in peripheral blood (cells/µL)
Measured: Day 300
Peripheral blood flow cytometry - neutrophils
Neutrophil concentration in peripheral blood (cells/µL)
Measured: Day 30
Peripheral blood flow cytometry - neutrophils
Neutrophil concentration in peripheral blood (cells/µL)
Measured: Day 300
Survival
Survival and time to death/cause of death (if applicable) of study subjects
Measured: baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start5 Jul 2019
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Jonathan A Galli, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562416
- Sponsor's protocol ID
- 1199-0329
- Status last verified
- Apr 2023
- First submitted
- 7 May 2018
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thabut G, Mal H, Castier Y, Groussard O, Brugiere O, Marrash-Chahla R, Leseche G, Fournier M. Survival benefit of lung transplantation for patients with idiopathic pulmonary fibrosis. J Thorac Cardiovasc Surg. 2003 Aug;126(2):469-75. doi: 10.1016/s0022-5223(03)00600-7.
PubMed 12928646Lund LH, Edwards LB, Dipchand AI, Goldfarb S, Kucheryavaya AY, Levvey BJ, Meiser B, Rossano JW, Yusen RD, Stehlik J; International Society for Heart and Lung Transplantation. The Registry of the International Society for Heart and Lung Transplantation: Thirty-third Adult Heart Transplantation Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant. 2016 Oct;35(10):1158-1169. doi: 10.1016/j.healun.2016.08.017. Epub 2016 Aug 21. No abstract available.
PubMed 27772668Schaffer JM, Singh SK, Reitz BA, Zamanian RT, Mallidi HR. Single- vs double-lung transplantation in patients with chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis since the implementation of lung allocation based on medical need. JAMA. 2015 Mar 3;313(9):936-48. doi: 10.1001/jama.2015.1175.
PubMed 25734735Elicker BM, Golden JA, Ordovas KG, Leard L, Golden TR, Hays SR. Progression of native lung fibrosis in lung transplant recipients with idiopathic pulmonary fibrosis. Respir Med. 2010 Mar;104(3):426-33. doi: 10.1016/j.rmed.2009.10.019. Epub 2009 Nov 12.
PubMed 19913395Wahidi MM, Ravenel J, Palmer SM, McAdams HP. Progression of idiopathic pulmonary fibrosis in native lungs after single lung transplantation. Chest. 2002 Jun;121(6):2072-6. doi: 10.1378/chest.121.6.2072.
PubMed 12065382Wollin L, Wex E, Pautsch A, Schnapp G, Hostettler KE, Stowasser S, Kolb M. Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis. Eur Respir J. 2015 May;45(5):1434-45. doi: 10.1183/09031936.00174914. Epub 2015 Mar 5.
PubMed 25745043Xu Z, Ramachandran S, Gunasekaran M, Zhou F, Trulock E, Kreisel D, Hachem R, Mohanakumar T. MicroRNA-144 dysregulates the transforming growth factor-beta signaling cascade and contributes to the development of bronchiolitis obliterans syndrome after human lung transplantation. J Heart Lung Transplant. 2015 Sep;34(9):1154-62. doi: 10.1016/j.healun.2015.03.021. Epub 2015 Mar 27.
PubMed 25979625Sjoland AA, Callerfelt AK, Thiman L, et al. Prostacyclin and VEGF in the rejection process after lung transplantation-A possible biomarker [abstract]. Eur Respir J. 2016; PA4040.
Suhling H, Bollmann B, Gottlieb J. Nintedanib in restrictive chronic lung allograft dysfunction after lung transplantation. J Heart Lung Transplant. 2016 Jul;35(7):939-40. doi: 10.1016/j.healun.2016.01.1220. Epub 2016 Feb 9. No abstract available.
PubMed 26996931Delanote I, Wuyts WA, Yserbyt J, Verbeken EK, Verleden GM, Vos R. Safety and efficacy of bridging to lung transplantation with antifibrotic drugs in idiopathic pulmonary fibrosis: a case series. BMC Pulm Med. 2016 Nov 18;16(1):156. doi: 10.1186/s12890-016-0308-z.
PubMed 27863518Dorey-Stein Z, Galli JA, Criner GJ. Effect of antifibrotic therapy in patients with idiopathic pulmonary fibrosis awaiting lung transplantation [abstract]. Am J Respir Crit Care Med. 2017;195:A5386
Leuschner G, Stocker F, Veit T, Kneidinger N, Winter H, Schramm R, Weig T, Matthes S, Ceelen F, Arnold P, Munker D, Klenner F, Hatz R, Frankenberger M, Behr J, Neurohr C. Outcome of lung transplantation in idiopathic pulmonary fibrosis with previous anti-fibrotic therapy. J Heart Lung Transplant. 2017 Jul 5:S1053-2498(17)31886-7. doi: 10.1016/j.healun.2017.07.002. Online ahead of print.
PubMed 28734935
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03562416
- Acronym / sponsor ID
- 1199-0329
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 19 Jun 2018 (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 aim of this study is to assess the utility of nintedanib therapy in addition to usual transplant care in single lung transplant recipients with idiopathic pulmonary fibrosis (IPF). The investigators hypothesize that in IPF subjects who undergo single lung transplantation the administration of nintedanib 150 mg twice daily in addition to usual transplant care will result in better preservation of lung function at 24 months.
Detailed description
Lung transplantation is the only treatment option that augments survival in patients with idiopathic pulmonary fibrosis (IPF). Despite several advancements in lung transplantation over the past three decades, long-term survival rates have remained low compared to other solid organ transplantations. The median survival after lung transplantation is only 5.8 years. Multiple factors account for the relatively low survival post-transplant, but chronic rejection resulting in obliterative bronchiolitis is a predominate cause. Further research is needed to develop medical therapeutic interventions that improve survival in IPF patients who undergo only single lung transplantation.
Nintedanib, a novel tyrosine kinase inhibitor, exhibits antifibrotic properties via multiple mechanisms including the inhibition of the receptor tyrosine kinases platelet derived growth factor (PDGF) receptor, fibroblast growth factor (FGF) receptor, and vascular endothelial growth factor (VEGF) receptor. Several mediators of pulmonary fibrosis including VEGF, FGF, and transforming growth factor beta (TGF-β) have also been implicated in the pathogenesis of bronchiolitis obliterans syndrome (BOS), the most common type of chronic lung allograft rejection.
Nintedanib is safe to continue until the time of lung transplantation and has not been shown to worsen perioperative outcomes in small case series, single center cohorts and our center's personal experience. The current practice in lung transplant medicine is to discontinue antifibrotic therapy after lung transplantation in IPF. In IPF patients who undergo single lung transplant, nintedanib therapy has the potential to preserve lung function in both the native fibrotic lung and the new lung allograft.
The investigators propose a randomized and placebo-controlled single center pilot trial comparing nintedanib therapy plus usual care to usual care only in IPF patients after single lung transplant. The investigators hypothesize that in IPF subjects who undergo single lung transplantation the administration of nintedanib 150 mg twice daily in addition to usual transplant care will result in better preservation of lung function at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib | Experimental | Drug: NintedanibNintedanib 150 mg tablet by mouth twice daily for 24 months. |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo tablet by mouth twice daily for 24 months |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults between the ages of 35-70.
- Lung transplantation listing diagnosis of pulmonary fibrosis
- Recipient of single lung transplantation within the past 60 days
Key exclusion criteria (9 listed)
- History of intolerability to nintedanib (i.e. discontinued nintedanib in the pre-transplant period due to adverse drug effects)
- Liver transaminase elevation (AST or ALT > 1.5X the upper limit of normal)
- Total bilirubin > 1.5X the upper limit of normal
- Drugs that interfere with the metabolism or elimination of nintedanib or its metabolites - St. John's wort, carbamazepine, phenytoin, rifampin, dexamethasone, and others.
- Any history of bronchial anastomosis dehiscence or stenosis
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 |
|---|---|---|
| NintedanibAlso: BIBF 1120, OfevNintedanib (BIBF 1120, Ofev) | Drug | Nintedanib |
| Placebo Oral TabletPlacebo | Drug | Placebo |
Primary outcome
Change in FEV1
Time frame: Baseline to 24 months
Change in forced expiratory volume in 1 second (FEV1)
Change in FVC
Time frame: Baseline to 24 months
Change in forced vital capacity (FVC)
27 secondary outcomes
Bronchiolitis obliterans syndrome
Time frame: Baseline to 24 months
Bronchial stenosis
Time frame: Baseline to 24 months
Bronchial dehiscence
Time frame: Baseline to 24 months
Acute cellular rejection
Time frame: Baseline to 24 months
Drug discontinuation
Time frame: Baseline to 24 months
Adverse drug events
Time frame: Baseline to 24 months
Vascular endothelial growth factor (VEGF) - serum
Time frame: Baseline to day 30
Vascular endothelial growth factor (VEGF) - BAL
Time frame: Baseline to day 30
Vascular endothelial growth factor (VEGF) - serum
Time frame: Baseline to day 300
Vascular endothelial growth factor (VEGF) - BAL
Time frame: Baseline to day 300
Fibroblast growth factor (FGF) - serum
Time frame: Baseline to day 30
Fibroblast growth factor (FGF) - BAL
Time frame: Baseline to day 30
Fibroblast growth factor (FGF) - serum
Time frame: Baseline to day 300
Fibroblast growth factor (FGF) - BAL
Time frame: Baseline to day 300
Platelet derived growth factor (PDGF) - serum
Time frame: Baseline to day 30
Platelet derived growth factor (PDGF) - BAL
Time frame: Baseline to day 30
Platelet derived growth factor (PDGF) - serum
Time frame: Baseline to day 300
Platelet derived growth factor (PDGF) - BAL
Time frame: Baseline to day 300
Peripheral blood flow cytometry - CD4 T cells
Time frame: Day 30
Peripheral blood flow cytometry - CD4 T cells
Time frame: Day 300
Peripheral blood flow cytometry - CD8 T cells
Time frame: Day 30
Peripheral blood flow cytometry - CD8 T cells
Time frame: Day 300
Peripheral blood flow cytometry - macrophages
Time frame: Day 30
Peripheral blood flow cytometry - macrophages
Time frame: Day 300
Peripheral blood flow cytometry - neutrophils
Time frame: Day 30
Peripheral blood flow cytometry - neutrophils
Time frame: Day 300
Survival
Time frame: baseline to 24 months
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 12928646Thabut G, Mal H, Castier Y, Groussard O, Brugiere O, Marrash-Chahla R, Leseche G, Fournier M. Survival benefit of lung transplantation for patients with idiopathic pulmonary fibrosis. J Thorac Cardiovasc Surg. 2003 Aug;126(2):469-75. doi: 10.1016/s0022-5223(03)00600-7.
- Background: PubMed 27772668Lund LH, Edwards LB, Dipchand AI, Goldfarb S, Kucheryavaya AY, Levvey BJ, Meiser B, Rossano JW, Yusen RD, Stehlik J; International Society for Heart and Lung Transplantation. The Registry of the International Society for Heart and Lung Transplantation: Thirty-third Adult Heart Transplantation Report-2016; Focus Theme: Primary Diagnostic Indications for Transplant. J Heart Lung Transplant. 2016 Oct;35(10):1158-1169. doi: 10.1016/j.healun.2016.08.017. Epub 2016 Aug 21. No abstract available.
- Background: PubMed 25734735Schaffer JM, Singh SK, Reitz BA, Zamanian RT, Mallidi HR. Single- vs double-lung transplantation in patients with chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis since the implementation of lung allocation based on medical need. JAMA. 2015 Mar 3;313(9):936-48. doi: 10.1001/jama.2015.1175.
- Background: PubMed 19913395Elicker BM, Golden JA, Ordovas KG, Leard L, Golden TR, Hays SR. Progression of native lung fibrosis in lung transplant recipients with idiopathic pulmonary fibrosis. Respir Med. 2010 Mar;104(3):426-33. doi: 10.1016/j.rmed.2009.10.019. Epub 2009 Nov 12.
- Background: PubMed 12065382Wahidi MM, Ravenel J, Palmer SM, McAdams HP. Progression of idiopathic pulmonary fibrosis in native lungs after single lung transplantation. Chest. 2002 Jun;121(6):2072-6. doi: 10.1378/chest.121.6.2072.
- Background: PubMed 25745043Wollin L, Wex E, Pautsch A, Schnapp G, Hostettler KE, Stowasser S, Kolb M. Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis. Eur Respir J. 2015 May;45(5):1434-45. doi: 10.1183/09031936.00174914. Epub 2015 Mar 5.
- Background: PubMed 25979625Xu Z, Ramachandran S, Gunasekaran M, Zhou F, Trulock E, Kreisel D, Hachem R, Mohanakumar T. MicroRNA-144 dysregulates the transforming growth factor-beta signaling cascade and contributes to the development of bronchiolitis obliterans syndrome after human lung transplantation. J Heart Lung Transplant. 2015 Sep;34(9):1154-62. doi: 10.1016/j.healun.2015.03.021. Epub 2015 Mar 27.
- BackgroundSjoland AA, Callerfelt AK, Thiman L, et al. Prostacyclin and VEGF in the rejection process after lung transplantation-A possible biomarker [abstract]. Eur Respir J. 2016; PA4040.
- Background: PubMed 26996931Suhling H, Bollmann B, Gottlieb J. Nintedanib in restrictive chronic lung allograft dysfunction after lung transplantation. J Heart Lung Transplant. 2016 Jul;35(7):939-40. doi: 10.1016/j.healun.2016.01.1220. Epub 2016 Feb 9. No abstract available.
- Background: PubMed 27863518Delanote I, Wuyts WA, Yserbyt J, Verbeken EK, Verleden GM, Vos R. Safety and efficacy of bridging to lung transplantation with antifibrotic drugs in idiopathic pulmonary fibrosis: a case series. BMC Pulm Med. 2016 Nov 18;16(1):156. doi: 10.1186/s12890-016-0308-z.
- BackgroundDorey-Stein Z, Galli JA, Criner GJ. Effect of antifibrotic therapy in patients with idiopathic pulmonary fibrosis awaiting lung transplantation [abstract]. Am J Respir Crit Care Med. 2017;195:A5386
- Background: PubMed 28734935Leuschner G, Stocker F, Veit T, Kneidinger N, Winter H, Schramm R, Weig T, Matthes S, Ceelen F, Arnold P, Munker D, Klenner F, Hatz R, Frankenberger M, Behr J, Neurohr C. Outcome of lung transplantation in idiopathic pulmonary fibrosis with previous anti-fibrotic therapy. J Heart Lung Transplant. 2017 Jul 5:S1053-2498(17)31886-7. doi: 10.1016/j.healun.2017.07.002. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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. This study is not recruiting at the moment.
Jonathan A Galli, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nintedanib in people with Idiopathic Pulmonary Fibrosis and Lung Transplant; Complications, run by Temple 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Change in FEV1 (time frame: Baseline to 24 months). The study lists 2 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 NCT03562416, which also lists 12 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 7 Apr 2023.