Status:
COMPLETED
Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Restrictive Chronic Lung Allograft Dysfunction
Lung Transplant Rejection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 approx...
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 year...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03359863
Start Date
March 7 2018
End Date
October 28 2021
Last Update
June 29 2023
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143