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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

320

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

April 15, 2019

Completed

3 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2019

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed

19 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed

Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

April 18, 2019

Last Update Submit

May 18, 2021

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Lung TransplantNintedanibPirfenidoneIPF

Outcome Measures

Primary Outcomes (8)

Lung transplant complications
The proportions of patients in each group who develop (a) intra-operative outcomes and complications (need for ECMO/cardiopulmonary bypass and blood transfusions) and (b) post-transplant outcomes and complications (mechanical ventilation days, number of days with air leak and chest tube, primary graft dysfunction, anastomotic dehiscence, wound dehiscence, sternal breakdown / dehiscence, post-op infection, post-operative return to OR, blood transfusions) will be calculated.
6 months
Short term survival
Post-transplant, patients will be followed for six months to estimate the mean, median, and variability of short-term survival in each group.
6 months
Patient deaths while awaiting a transplant
The proportion of patients in each of the six groups who die after being listed and prior to receiving a transplant.
From date of listed for transplant until the date of death from any cause assessed up to 54 months.
Disease progression while awaiting a transplant
Changes in forced vital capacity (FVC) as measured in liters will be compared between groups.
From date of listed for transplant until the date of transplant or date of death from any cause assessed up to 54 months.
Disease progression while awaiting a transplant
Changes in percent predicted forced vital capacity (FVC%) as measured in percentage will be compared between groups.
From date of listed for transplant until the date of transplant or date of death from any cause assessed up to 54 months.
Disease progression while awaiting a transplant
Changes in diffusing capacity of the lung for carbon monoxide (DLCO) as measured in ml/mmHg/min will be compared between groups.
From date of listed for transplant until the date of transplant or date of death from any cause assessed up to 54 months.
Disease progression while awaiting a transplant
Changes in percent predicted diffusing capacity of the lung for carbon monoxide (DLCO%) as measured in percentage will be compared between groups.
From date of listed for transplant until the date of transplant or date of death from any cause assessed up to 54 months.
Disease progression while awaiting a transplant
Changes in Lung Allocation Score (scale from 0-100; higher score reflecting higher priority for transplant) will be compared between groups.
From date of listed for transplant until the date of transplant or date of death from any cause assessed up to 54 months.