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Impact of Pre-transplant Anti-fibrotic Therapy for IPF Upon Lung Transplant Outcomes

NCT04316780 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2021-05-20

No results posted yet for this study

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 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.

Conditions

Interventions

OTHER

Retrospective observational study- no intervention to occur.

Subject data will be grouped based on the anti-fibrotic medication at the time of lung transplant listing eligibility and when medication was stopped relative to the transplant.

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Steward St. Elizabeth's Medical Center of Boston, Inc.

    lead OTHER

Principal Investigators

  • Peter LaCamera, M.D. · St. Elizabeth's Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2019-12-31
Completion
2020-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316780 on ClinicalTrials.gov