Impact of Pre-transplant Anti-fibrotic Therapy for IPF Upon Lung Transplant Outcomes
Public ClinicalTrials.gov record NCT04316780. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Impact of Pre-transplant Anti-fibrotic Therapy for Idiopathic Pulmonary Fibrosis Upon Lung Transplant Outcomes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 proved to slow the progression of disease in their respective clinical trials. Because of their anti-fibrotic properties, there have been concerns about the potential of these medications to impair wound healing following surgery. These concerns have led to variable approaches with respect to the management of the medications in patients listed for lung transplantation. It is unknown whether continuing anti-fibrotic medications until the time of transplant increases the risks of intra-operative and post-transplant complications. Conversely, there are concerns that stopping the medications prematurely may promote a more rapid clinical decline in those awaiting transplantation and increase risk of death while on waiting lists. Whether there is a risk or benefit of continuing the medications during the pre-transplant period deserves investigation with the goal of establishing guidelines and best-practices. Once more is known about how best to manage anti-fibrotic therapy in the pre-transplant period, the question of whether these medications should be restarted following transplantation will also ultimately deserve exploration.
Study identification
- NCT ID
- NCT04316780
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 320 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 15, 2019 (Actual)
- Primary completion
- Dec 31, 2019 (Actual)
- Completion
- Mar 1, 2020 (Actual)
- Last update posted
- May 20, 2021
2019 – 2020
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Temple University | Philadelphia | Pennsylvania | 19122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04316780, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2021 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04316780 live on ClinicalTrials.gov.