Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 17 April 2023
• Main ID: NCT03562416
• Date of registration: 07/05/2018
• Prospective Registration: Yes
• Primary sponsor: Temple University
• Public title: Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects
• Scientific 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
• Date of first enrolment: July 5, 2019
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03562416
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jonathan A Galli, MD
• Affiliation: Temple University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults between the ages of 35-70.

- Lung transplantation listing diagnosis of pulmonary fibrosis

- Recipient of single lung transplantation within the past 60 days

Exclusion Criteria:

- 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:

- 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



Age minimum: 35 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Lung Transplant; Complications

Intervention(s)

Drug: Nintedanib

Drug: Placebo Oral Tablet

Primary Outcome(s)

Change in FEV1 [Time Frame: Baseline to 24 months]

Change in FVC [Time Frame: Baseline to 24 months]

Secondary Outcome(s)

Acute cellular rejection [Time Frame: Baseline to 24 months]

Peripheral blood flow cytometry - neutrophils [Time Frame: Day 30]

Peripheral blood flow cytometry - neutrophils [Time Frame: Day 300]

Platelet derived growth factor (PDGF) - serum [Time Frame: Baseline to day 300]

Peripheral blood flow cytometry - CD4 T cells [Time Frame: Day 300]

Platelet derived growth factor (PDGF) - BAL [Time Frame: Baseline to day 30]

Platelet derived growth factor (PDGF) - BAL [Time Frame: Baseline to day 300]

Survival [Time Frame: baseline to 24 months]

Bronchial dehiscence [Time Frame: Baseline to 24 months]

Bronchial stenosis [Time Frame: Baseline to 24 months]

Fibroblast growth factor (FGF) - BAL [Time Frame: Baseline to day 300]

Fibroblast growth factor (FGF) - serum [Time Frame: Baseline to day 30]

Peripheral blood flow cytometry - CD4 T cells [Time Frame: Day 30]

Platelet derived growth factor (PDGF) - serum [Time Frame: Baseline to day 30]

Fibroblast growth factor (FGF) - serum [Time Frame: Baseline to day 300]

Peripheral blood flow cytometry - CD8 T cells [Time Frame: Day 30]

Fibroblast growth factor (FGF) - 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 30]

Vascular endothelial growth factor (VEGF) - BAL [Time Frame: Baseline to day 300]

Bronchiolitis obliterans syndrome [Time Frame: Baseline to 24 months]

Drug discontinuation [Time Frame: Baseline to 24 months]

Adverse drug events [Time Frame: Baseline to 24 months]

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]

Vascular endothelial growth factor (VEGF) - serum [Time Frame: Baseline to day 30]

Secondary ID(s)

1199-0329

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim