Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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). 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Collaborator: Boehringer Ingelheim
• Treatments: Nintedanib

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