Status:
COMPLETED
Impact of Pre-transplant Anti-fibrotic Therapy for IPF Upon Lung Transplant Outcomes
Lead Sponsor:
Steward St. Elizabeth's Medical Center of Boston, Inc.
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
Brief Summary
Two oral medications, nintedanib and pirfenidone, were approved simultaneously by the FDA in October 2014 for the treatment of this disease. They are both considered anti-fibrotic agents and they each...
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is a terminal illness that typically develops in the sixth and seventh decades of life. It is a relentless fibrotic parenchymal lung disease that results in restric...
Eligibility Criteria
Inclusion
- Diagnosis of IPF
- Taking one of the two anti-fibrotic therapies (nintedanib or pirfenidone) continuously for at least 90 days at the time of eligibility for listing
- Listed for lung transplantation between July 1, 2015 and June 30, 2019
Exclusion
- 1\. Patients that underwent additional interventions (i.e. coronary artery bypass grafting, valve replacement) at the time of their lung transplant
Key Trial Info
Start Date :
April 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04316780
Start Date
April 15 2019
End Date
March 1 2020
Last Update
May 20 2021
Active Locations (8)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Washington University in St. Louis
St Louis, Missouri, United States, 63110