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NCT04316780 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Steward St. Elizabeth's Medical Center of Boston.

Completed
Registry status
320
Enrollment target

NCT04316780 is a clinical trial that has completed, run by Steward St. Elizabeth's Medical Center of Boston. The registered enrollment target is 320 participants.

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The verdict

NCT04316780 has completed, sponsored by Steward St. Elizabeth's Medical Center of Boston.

COMPLETED
Registry status
320 participants
Enrollment target

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.

Interventions

  • OTHER Retrospective observational study- no intervention to occur.

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2019-04-15
Est. Completion 2020-03-01

What the Registry Record Tells You About NCT04316780

The ClinicalTrials.gov registry entry for NCT04316780 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Steward St. Elizabeth's Medical Center of Boston, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Retrospective observational study- no intervention to occur. is the first listed.

NCT04316780 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04316780 about?

NCT04316780 is a clinical study titled "Impact of Pre-transplant Anti-fibrotic Therapy for IPF Upon Lung Transplant Outcomes". 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 ant...

What is the current status of trial NCT04316780?

This trial is currently completed. The enrollment target is 320 participants. The study started on 2019-04-15. Estimated completion is 2020-03-01.

What interventions are being tested in trial NCT04316780?

The interventions under investigation include: Retrospective observational study- no intervention to occur. (OTHER).

Who is sponsoring clinical trial NCT04316780?

This trial is sponsored by Steward St. Elizabeth's Medical Center of Boston, which has 18 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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