Restrictive Chronic Lung Allograft DysfunctionPhase 2PIRCLADNCT03359863

Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction

A Phase 2 study testing Pirfenidone in people with Restrictive Chronic Lung Allograft Dysfunction and Lung Transplant Rejection, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Restrictive Chronic Lung Allograft Dysfunction, Lung Transplant Rejection
What is being tested?: Pirfenidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 7 Mar 2018to 28 Oct 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject who underwent bilateral lung transplantation at University of California San Francisco (UCSF) and have a diagnosis of RCLAD based on the International Heart and Lung Transplant (ISHLT) classification. The diagnosis of RCLAD is based on spirometry (Forced Expiratory Volume in 1 second (FEV1) ≤ 80% and FVC ≤ 80% of best post-transplant baseline) and CT scan (e.g. pleuroparenchymal fibroelastosis) findings.

Who cannot join

FVC decline related to non-RCLAD causes (e.g. pulmonary edema, pleural effusion, etc).
Patients with any severe comorbidity complicating RCLAD which might determine their prognosis and functional level (e.g. active malignant disease) within the last 12 months
Patients who have resumed smoking after transplantation
Renal insufficiency (creatinine clearance < 30 ml/min calculated by the CKD-Epi formula)
Total bilirubin above the upper limit of the normal range (ULN)
Aspartate or alanine aminotransferase (AST or ALT) > 3 times the ULN.

Show all 12Show fewer

Known allergy of hypersensitivity to Pirfenidone
Pregnancy
Ongoing use or expected use of any of the following therapies:
Strong inhibitors of CYP1A2 (e.g. fluvoxamine or enoxacin).
Moderate inhibitors of CAYP1A2 (e. g. mexiletine, thiabendazole, or phenylpropanolamine). Ciprofloxacin will be allowed only at doses equal or less than 500 mg BID.
Inability to provide informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Despite advances in lung transplantation, the median survival remains only 55% at 5 years. The main limitation to long term survival is the development of chronic lung allograft dysfunction. In approximately 30% of cases, chronic lung allograft dysfunction has a restrictive phenotype (RCLAD) characterized by fibrosis with rapid progression to respiratory failure. Approximately 60% of patients with RCLAD die within one year, as currently there are no therapies available.

RCLAD, like Idiopathic Pulmonary Fibrosis (IPF), is characterized by fibroblast proliferation, extracellular matrix deposition, and architectural distortion leading to progressive lung scarring and death. Given their similarities, there is keen interest in the international transplant community to investigate whether the anti-fibrotic drug pirfenidone can slow the progression of RCLAD as it does of IPF. Pirfenidone has been proved to be safe and effective in patients with IPF, and is approved by the Food and Drug Administration.

This protocol will evaluate the safety and tolerability of pirfenidone in lung transplant recipients with RCLAD. Transplant recipients take carefully adjusted immunosuppressive medications for life to prevent rejection of the allograft. Current literature suggests the dose of tacrolimus, the main anti-rejection drug, may need to be adjusted when taken in combination with pirfenidone. The investigators will assess the side effects of pirfenidone in combination with the immunosuppressive regimen and determine the magnitude of the adjustment in tacrolimus dose. The results of this pilot study will provide the foundation for a multicenter randomized control trial to evaluate the efficacy of pirfenidone in slowing the progression of RCLAD.

Read the detailed description

Despite advances in lung transplantation, median survival remains only 55% at 5 years. The primary cause of death is chronic lung allograft dysfunction (CLAD), occurring in 43% of recipients at 5 years. Recently, it has been recognized that CLAD can have an obstructive (BOS) or a restrictive (RCLAD) phenotype, also known as restrictive allograft syndrome (RAS), and that both may coexist. These phenotypes differ not only in their spirometric, radiographic and histologic features but also in their rates of progression and survival. Thus, there is a critical need to find therapies other than re-transplantation, which remains the only effective therapeutic option and explore the pathobiology driving RCLAD.

RCLAD shares features with Idiopathic Pulmonary Fibrosis (IPF), including its progressive and lethal course, extracellular matrix deposition, architectural distortion, fibroblast proliferation, and short telomeres in lung epithelial cells. These common features suggest RCLAD and IPF may share molecular pathogenesis. As a result, some have explored using FDA approved anti-fibrotic medications for IPF in RCLAD in case reports.

This proposal aims to gather the preliminary data needed to design a multicenter randomized controlled trial (RCT) of pirfenidone for RCLAD. To do so, the investigators first need evidence of tolerability, to understand drug interactions with the immunosuppressive regimen used to maintain allograft function and early evidence that pirfenidone may slow FVC decline and radiographic progression in RCLAD.

Evidence that pirfenidone is well tolerated in transplant recipients and that it slows the progression of RCLAD would be paradigm shifting. Further, identifying subjects at risk for RCLAD before the onset of spirometric changes would allow to start therapeutic interventions sooner, maximizing their benefit. Finding biomarkers that predict response to pirfenidone would identify patients most likely to benefit.

Conditions: Restrictive Chronic Lung Allograft Dysfunction, Lung Transplant Rejection
Being tested: Pirfenidone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PirfenidoneDrug
Also called Esbriet
Subjects will receive pirfenidone for 52 weeks, titrated to 2403 mg/day (3 capsules, 3× daily) after a 4-week titration period (1 capsule, 3x daily for 2 weeks, 2 capsules, 3x daily for 2 weeks) for a total of 56 weeks of pirfenidone. Eligible participants will continue pirfenidone beyond 56 weeks.

Study groups in NCT03359863
Study group	Role	What they receive
Treatment Arm	Experimental	Subjects will receive Pirfenidone as part of treatment for their restrictive chronic lung allograft dysfunction (RCLAD). Receives: Drug: Pirfenidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability of Pirfenidone
The primary outcome will be the number of subjects that discontinue pirfenidone due to a treatment emergent adverse event (TEAE)
Measured: From initiation of pirfenidone until discontinuation or until 56 weeks, which ever comes first.
Conversion Ratio of Tacrolimus Dose
The outcome will be the ratio of tacrolimus-while-taking-pirfenidone to tacrolimus-before-pirfenidone corrected for the subject's specific steady-state tacrolimus concentration.
Measured: From initiation of pirfenidone until discontinuation or until 56 weeks, which ever comes first.

Secondary outcomes (4)

Annual Change in Forced Vital Capacity (FVC)
The investigators will evaluate change in FVC from baseline to 1 year after pirfenidone start based on pulmonary function tests done as part of routine clinical care (usually obtained every 3 months) or death, whichever comes first.
Measured: FVC change from baseline (screening) to 1 year or death, whichever comes first.
Annual Change in Forced Expiratory Volume in 1 Second (FEV1)
The investigators will evaluate change in FEV1 from baseline to 1 year based on pulmonary function tests done as part of routine clinical care (usually obtained every 3 months) or death, whichever comes first.
Measured: FEV1 change from baseline (screening) to 1 year or death, whichever comes first.
Annual Change in Percent of Lung Affected by Reticulation on Chest CT Scan
The investigators will evaluate the annual change in percent of lung affected by reticulation comparing the chest CT scan at screening and a 1-year follow up CT scan performed as part of routine clinical care or death, whichever comes first.
Measured: Change between chest CT at screening and in 1-year follow up CT scan performed as part of routine clinical care or death, whichever comes first.
Annual Change in Traction Bronchiectasis Score on Chest CT Scan
The investigators will evaluate the change in traction bronchiectasis score on chest CT scan at screening and in a 1-year follow up CT scan performed as part of routine clinical care or death, whichever comes first. The extent of traction bronchiectasis was first scored in each of the six lung lobes separately (right upper, middle, and lower lobes, and left upper, lingula, and lower lobes) as 0-absent, 1-mild, 2-moderate, or 3-severe, and then summed into a total traction bronchiectasis score [range 0-18 points], with higher values reflecting greater extent of traction bronchiectasis.
Measured: Change between Chest CT at screening and 1-year follow up CT scan performed as part of routine clinical care or death, whichever comes first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Mar 201828 Oct 2021

First posted2 Dec 2017
Study start7 Mar 2018
Primary completion28 Oct 2021
Study completion28 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Restrictive Chronic Lung Allograft DysfunctionStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03359863
Sponsor's protocol ID: 16-20710
Acronym: PIRCLAD
Status last verified: Jun 2023
First submitted: 15 Nov 2017
Last updated: 29 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Valapour M, Skeans MA, Smith JM, Edwards LB, Cherikh WS, Callahan ER, Israni AK, Snyder JJ, Kasiske BL. Lung. Am J Transplant. 2016 Jan;16 Suppl 2:141-68. doi: 10.1111/ajt.13671.
PubMed 26755267
Verleden GM, Raghu G, Meyer KC, Glanville AR, Corris P. A new classification system for chronic lung allograft dysfunction. J Heart Lung Transplant. 2014 Feb;33(2):127-33. doi: 10.1016/j.healun.2013.10.022. Epub 2013 Oct 24.
PubMed 24374027
Saito T, Horie M, Sato M, Nakajima D, Shoushtarizadeh H, Binnie M, Azad S, Hwang DM, Machuca TN, Waddell TK, Singer LG, Cypel M, Liu M, Paul NS, Keshavjee S. Low-dose computed tomography volumetry for subtyping chronic lung allograft dysfunction. J Heart Lung Transplant. 2016 Jan;35(1):59-66. doi: 10.1016/j.healun.2015.07.005. Epub 2015 Aug 13.
PubMed 26342441
Pakhale SS, Hadjiliadis D, Howell DN, Palmer SM, Gutierrez C, Waddell TK, Chaparro C, Davis RD, Keshavjee S, Hutcheon MA, Singer LG. Upper lobe fibrosis: a novel manifestation of chronic allograft dysfunction in lung transplantation. J Heart Lung Transplant. 2005 Sep;24(9):1260-8. doi: 10.1016/j.healun.2004.08.026.
PubMed 16143243
Ofek E, Sato M, Saito T, Wagnetz U, Roberts HC, Chaparro C, Waddell TK, Singer LG, Hutcheon MA, Keshavjee S, Hwang DM. Restrictive allograft syndrome post lung transplantation is characterized by pleuroparenchymal fibroelastosis. Mod Pathol. 2013 Mar;26(3):350-6. doi: 10.1038/modpathol.2012.171. Epub 2012 Sep 28.
PubMed 23018877
Sato M, Hwang DM, Waddell TK, Singer LG, Keshavjee S. Progression pattern of restrictive allograft syndrome after lung transplantation. J Heart Lung Transplant. 2013 Jan;32(1):23-30. doi: 10.1016/j.healun.2012.09.026.
PubMed 23260703
Sato M, Waddell TK, Wagnetz U, Roberts HC, Hwang DM, Haroon A, Wagnetz D, Chaparro C, Singer LG, Hutcheon MA, Keshavjee S. Restrictive allograft syndrome (RAS): a novel form of chronic lung allograft dysfunction. J Heart Lung Transplant. 2011 Jul;30(7):735-42. doi: 10.1016/j.healun.2011.01.712. Epub 2011 Mar 17.
PubMed 21419659
Todd JL, Jain R, Pavlisko EN, Finlen Copeland CA, Reynolds JM, Snyder LD, Palmer SM. Impact of forced vital capacity loss on survival after the onset of chronic lung allograft dysfunction. Am J Respir Crit Care Med. 2014 Jan 15;189(2):159-66. doi: 10.1164/rccm.201306-1155OC.
PubMed 24325429
Verleden SE, de Jong PA, Ruttens D, Vandermeulen E, van Raemdonck DE, Verschakelen J, Vanaudenaerde BM, Verleden GM, Vos R. Functional and computed tomographic evolution and survival of restrictive allograft syndrome after lung transplantation. J Heart Lung Transplant. 2014 Mar;33(3):270-7. doi: 10.1016/j.healun.2013.12.011. Epub 2013 Dec 17.
PubMed 24461432
Verleden GM, Vos R, Verleden SE, De Wever W, De Vleeschauwer SI, Willems-Widyastuti A, Scheers H, Dupont LJ, Van Raemdonck DE, Vanaudenaerde BM. Survival determinants in lung transplant patients with chronic allograft dysfunction. Transplantation. 2011 Sep 27;92(6):703-8. doi: 10.1097/TP.0b013e31822bf790.
PubMed 21836537
Woodrow JP, Shlobin OA, Barnett SD, Burton N, Nathan SD. Comparison of bronchiolitis obliterans syndrome to other forms of chronic lung allograft dysfunction after lung transplantation. J Heart Lung Transplant. 2010 Oct;29(10):1159-64. doi: 10.1016/j.healun.2010.05.012. Epub 2010 Jun 26.
PubMed 20580267
Verleden SE, Ruttens D, Vandermeulen E, Bellon H, Dubbeldam A, De Wever W, Dupont LJ, Van Raemdonck DE, Vanaudenaerde BM, Verleden GM, Benden C, Vos R. Predictors of survival in restrictive chronic lung allograft dysfunction after lung transplantation. J Heart Lung Transplant. 2016 Sep;35(9):1078-84. doi: 10.1016/j.healun.2016.03.022. Epub 2016 Apr 16.
PubMed 27212563
Verleden SE, Todd JL, Sato M, Palmer SM, Martinu T, Pavlisko EN, Vos R, Neyrinck A, Van Raemdonck D, Saito T, Oishi H, Keshavjee S, Greer M, Warnecke G, Gottlieb J, Haverich A. Impact of CLAD Phenotype on Survival After Lung Retransplantation: A Multicenter Study. Am J Transplant. 2015 Aug;15(8):2223-30. doi: 10.1111/ajt.13281. Epub 2015 Apr 30.
PubMed 25940517
Fernandez IE, Heinzelmann K, Verleden S, Eickelberg O. Characteristic patterns in the fibrotic lung. Comparing idiopathic pulmonary fibrosis with chronic lung allograft dysfunction. Ann Am Thorac Soc. 2015 Mar;12 Suppl 1:S34-41. doi: 10.1513/AnnalsATS.201410-476MG.
PubMed 25830833
Alder JK, Chen JJ, Lancaster L, Danoff S, Su SC, Cogan JD, Vulto I, Xie M, Qi X, Tuder RM, Phillips JA 3rd, Lansdorp PM, Loyd JE, Armanios MY. Short telomeres are a risk factor for idiopathic pulmonary fibrosis. Proc Natl Acad Sci U S A. 2008 Sep 2;105(35):13051-6. doi: 10.1073/pnas.0804280105. Epub 2008 Aug 27.
PubMed 18753630

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction
ClinicalTrials.gov ID: NCT03359863
Acronym / sponsor ID: PIRCLAD / 16-20710
Conditions: Restrictive Chronic Lung Allograft Dysfunction, Lung Transplant Rejection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: 7 Mar 2018 (actual)
Primary completion: 28 Oct 2021 (actual)
Study completion: 28 Oct 2021 (actual)
First posted: 2 Dec 2017 (actual)
Results: Posted 9 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment Arm	Experimental	Drug: PirfenidoneSubjects will receive Pirfenidone as part of treatment for their restrictive chronic lung allograft dysfunction (RCLAD).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subject who underwent bilateral lung transplantation at University of California San Francisco (UCSF) and have a diagnosis of RCLAD based on the International Heart and Lung Transplant (ISHLT) classification. The diagnosis of RCLAD is based on spirometry (Forced Expiratory Volume in 1 second (FEV1) ≤ 80% and FVC ≤ 80% of best post-transplant baseline) and CT scan (e.g. pleuroparenchymal fibroelastosis) findings.

Key exclusion criteria (12 listed)

FVC decline related to non-RCLAD causes (e.g. pulmonary edema, pleural effusion, etc).
Patients with any severe comorbidity complicating RCLAD which might determine their prognosis and functional level (e.g. active malignant disease) within the last 12 months
Patients who have resumed smoking after transplantation
Renal insufficiency (creatinine clearance < 30 ml/min calculated by the CKD-Epi formula)
Total bilirubin above the upper limit of the normal range (ULN)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PirfenidoneAlso: EsbrietSubjects will receive pirfenidone for 52 weeks, titrated to 2403 mg/day (3 capsules, 3× daily) after a 4-week titration period (1 capsule, 3x daily for 2 weeks, 2 capsules, 3x daily for 2 weeks) for a total of 56 weeks of pirfenidone. Eligible participants will continue pirfenidone beyond 56 weeks.	Drug	Treatment Arm

Primary outcome

Tolerability of Pirfenidone
Time frame: From initiation of pirfenidone until discontinuation or until 56 weeks, which ever comes first.
The primary outcome will be the number of subjects that discontinue pirfenidone due to a treatment emergent adverse event (TEAE)
Conversion Ratio of Tacrolimus Dose
Time frame: From initiation of pirfenidone until discontinuation or until 56 weeks, which ever comes first.
The outcome will be the ratio of tacrolimus-while-taking-pirfenidone to tacrolimus-before-pirfenidone corrected for the subject's specific steady-state tacrolimus concentration.

4 secondary outcomes

Annual Change in Forced Vital Capacity (FVC)
Time frame: FVC change from baseline (screening) to 1 year or death, whichever comes first.
Annual Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: FEV1 change from baseline (screening) to 1 year or death, whichever comes first.
Annual Change in Percent of Lung Affected by Reticulation on Chest CT Scan
Time frame: Change between chest CT at screening and in 1-year follow up CT scan performed as part of routine clinical care or death, whichever comes first.
Annual Change in Traction Bronchiectasis Score on Chest CT Scan
Time frame: Change between Chest CT at screening and 1-year follow up CT scan performed as part of routine clinical care or death, whichever comes first.

Results and safety

Results posted to the registry on 9 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm	10	5

Primary outcome: Tolerability of Pirfenidone

Time frame: From initiation of pirfenidone until discontinuation or until 56 weeks, which ever comes first.. Count of participants. Unit: Participants

Measure	Treatment Arm n = 10
Value	3

Primary outcome: Conversion Ratio of Tacrolimus Dose

Time frame: From initiation of pirfenidone until discontinuation or until 56 weeks, which ever comes first.. Mean (Standard Deviation). Unit: conversion ratio

Measure	Treatment Arm n = 10
Value	1.1 (0.6)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 56 weeks for each participant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	7 of 10 (70%)	10 of 10 (100%)	3 of 10

Limitations and caveats (from the sponsor): Small, single-center cohort with an open-label intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26755267Valapour M, Skeans MA, Smith JM, Edwards LB, Cherikh WS, Callahan ER, Israni AK, Snyder JJ, Kasiske BL. Lung. Am J Transplant. 2016 Jan;16 Suppl 2:141-68. doi: 10.1111/ajt.13671.
Background: PubMed 24374027Verleden GM, Raghu G, Meyer KC, Glanville AR, Corris P. A new classification system for chronic lung allograft dysfunction. J Heart Lung Transplant. 2014 Feb;33(2):127-33. doi: 10.1016/j.healun.2013.10.022. Epub 2013 Oct 24.
Background: PubMed 26342441Saito T, Horie M, Sato M, Nakajima D, Shoushtarizadeh H, Binnie M, Azad S, Hwang DM, Machuca TN, Waddell TK, Singer LG, Cypel M, Liu M, Paul NS, Keshavjee S. Low-dose computed tomography volumetry for subtyping chronic lung allograft dysfunction. J Heart Lung Transplant. 2016 Jan;35(1):59-66. doi: 10.1016/j.healun.2015.07.005. Epub 2015 Aug 13.
Background: PubMed 16143243Pakhale SS, Hadjiliadis D, Howell DN, Palmer SM, Gutierrez C, Waddell TK, Chaparro C, Davis RD, Keshavjee S, Hutcheon MA, Singer LG. Upper lobe fibrosis: a novel manifestation of chronic allograft dysfunction in lung transplantation. J Heart Lung Transplant. 2005 Sep;24(9):1260-8. doi: 10.1016/j.healun.2004.08.026.
Background: PubMed 23018877Ofek E, Sato M, Saito T, Wagnetz U, Roberts HC, Chaparro C, Waddell TK, Singer LG, Hutcheon MA, Keshavjee S, Hwang DM. Restrictive allograft syndrome post lung transplantation is characterized by pleuroparenchymal fibroelastosis. Mod Pathol. 2013 Mar;26(3):350-6. doi: 10.1038/modpathol.2012.171. Epub 2012 Sep 28.
Background: PubMed 23260703Sato M, Hwang DM, Waddell TK, Singer LG, Keshavjee S. Progression pattern of restrictive allograft syndrome after lung transplantation. J Heart Lung Transplant. 2013 Jan;32(1):23-30. doi: 10.1016/j.healun.2012.09.026.
Background: PubMed 21419659Sato M, Waddell TK, Wagnetz U, Roberts HC, Hwang DM, Haroon A, Wagnetz D, Chaparro C, Singer LG, Hutcheon MA, Keshavjee S. Restrictive allograft syndrome (RAS): a novel form of chronic lung allograft dysfunction. J Heart Lung Transplant. 2011 Jul;30(7):735-42. doi: 10.1016/j.healun.2011.01.712. Epub 2011 Mar 17.
Background: PubMed 24325429Todd JL, Jain R, Pavlisko EN, Finlen Copeland CA, Reynolds JM, Snyder LD, Palmer SM. Impact of forced vital capacity loss on survival after the onset of chronic lung allograft dysfunction. Am J Respir Crit Care Med. 2014 Jan 15;189(2):159-66. doi: 10.1164/rccm.201306-1155OC.
Background: PubMed 24461432Verleden SE, de Jong PA, Ruttens D, Vandermeulen E, van Raemdonck DE, Verschakelen J, Vanaudenaerde BM, Verleden GM, Vos R. Functional and computed tomographic evolution and survival of restrictive allograft syndrome after lung transplantation. J Heart Lung Transplant. 2014 Mar;33(3):270-7. doi: 10.1016/j.healun.2013.12.011. Epub 2013 Dec 17.
Background: PubMed 21836537Verleden GM, Vos R, Verleden SE, De Wever W, De Vleeschauwer SI, Willems-Widyastuti A, Scheers H, Dupont LJ, Van Raemdonck DE, Vanaudenaerde BM. Survival determinants in lung transplant patients with chronic allograft dysfunction. Transplantation. 2011 Sep 27;92(6):703-8. doi: 10.1097/TP.0b013e31822bf790.
Background: PubMed 20580267Woodrow JP, Shlobin OA, Barnett SD, Burton N, Nathan SD. Comparison of bronchiolitis obliterans syndrome to other forms of chronic lung allograft dysfunction after lung transplantation. J Heart Lung Transplant. 2010 Oct;29(10):1159-64. doi: 10.1016/j.healun.2010.05.012. Epub 2010 Jun 26.
Background: PubMed 27212563Verleden SE, Ruttens D, Vandermeulen E, Bellon H, Dubbeldam A, De Wever W, Dupont LJ, Van Raemdonck DE, Vanaudenaerde BM, Verleden GM, Benden C, Vos R. Predictors of survival in restrictive chronic lung allograft dysfunction after lung transplantation. J Heart Lung Transplant. 2016 Sep;35(9):1078-84. doi: 10.1016/j.healun.2016.03.022. Epub 2016 Apr 16.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aida A Venado Estrada, MD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability of Pirfenidone (time frame: From initiation of pirfenidone until discontinuation or until 56 weeks, which ever comes first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03359863, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.