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Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)

A Phase Two Randomized, Double-blinded, Placebo-controlled Study Combining Physiological, Radiographic, and Biological Biomarkers to Study the Anti-fibrotic Effect of Pirfenidone in CLAD Post Lung-transplantation

NCT03473340•University of Michigan

View on ClinicalTrials.gov

Summary

Greater than 50% of lung transplant recipients show signs of chronic lung allograft dysfunction (CLAD) by 5 years post-transplantation.Therapies to prevent or slow CLAD are lacking. Anti-fibrotic therapies may offer an avenue to prevent progression of CLAD and prolong allograft survival. This study investigates if Pirfenidone therapy will stabilize lung function decline and slow progression of Functional small airways disease (fSAD) in lung transplant recipients with CLAD.

Detailed Description

The study aimed to enroll lung transplant recipients with an established diagnosis of CLAD. The patients were randomized to receive an anti-fibrotic drug Pirfenidone or Placebo pills for 6 month period. High-resolution CT scan of the chest was utilized to measure the primary endpoint of change in functional small airway disease (fSAD). Pulmonary function testing and spirometry were utilized to measure the secondary endpoint of change in FEV1 and FVC.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Lung transplant recipients 18 years of age or older
•Greater than 6 months after single or bilateral lung transplantation
•Baseline FEV1 and FVC values (mean of two highest value measured 3 weeks apart) \> 50% predicted (to assure viable graft)
•Diagnosis of CLAD (two consecutive spirometric values of FEV1 alone or both FEV1 and FVC \< 80% of baseline)

Exclusion Criteria

•Acute Rejection (AR) diagnosis by biopsy in the 28 days prior to enrollment
•Treatment with pulse steroids, Anti-thymocyte Globulin (ATG), extracorporeal photopheresis (ECP), plasmapheresis, or Immunoglobulin therapy aimed at CLAD within the 28 days prior to enrollment
•If the subject is receiving chronic Azithromycin therapy, the dose must be stable for the 28 days prior to enrollment
•Presence of active pulmonary infection at the time of enrollment as determined by an investigator in consultation with the treating pulmonologist
•Diagnosis of bronchial stenosis either a) requiring stenting, or b) thought to be responsible for the spirometric decline by principal investigator
•Abnormal liver function tests (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 x upper limit of normal (ULN), Alkaline phosphatase \> 2.5 x ULN, total bilirubin \> ULN) or known cirrhosis (\>2 times upper limit of normal of AST/ALT/AP)
•Total white blood cell (WBC) \< 3.0 K/uL
•Moderate to Severe Renal insufficiency (CrCl \<15 mL/min calculated by the Cockcroft-Gault equation)
•Use of any medication known to cause significant interactions with pirfenidone (strong CYP1A2 inhibitors such as Fluvoxamine or Enoxacin or inducers)
•Pregnancy or lactation. Women of child-bearing potential will have a pregnancy test at enrollment and must agree to maintain highly effective contraception with two methods of birth control from the date of consent through the end of the study.
+6 more criteria

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

April 27, 2018

Primary Completion Date

July 23, 2021

Completion Date

August 20, 2021

Last Updated

August 17, 2022

Enrollment

ACTUAL participants

Conditions

Disorder Related to Lung TransplantationChronic Lung Allograft Dysfunction

Interventions

Pirfenidone Capsule

DRUG

Placebo Capsule

DRUG

LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

NCT06018766

Bronchiolitis Obliterans SyndromeChronic Lung Allograft Dysfunction+1 more

View study

COMPLETED

Prospective Evaluations of Infectious Complication in Lung Transplant Recipients

NCT00177918

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)

Inclusion Criteria

Exclusion Criteria

LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

Prospective Evaluations of Infectious Complication in Lung Transplant Recipients

Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung

Morphofunctional Lung Analysis by PET and CT After Lung Transplantation