Status:
TERMINATED
Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Disorder Related to Lung Transplantation
Chronic Lung Allograft Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ther...
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 perio...
Eligibility Criteria
Inclusion
- 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.
- Tobacco use within 6 months
- History of alcohol abuse in the past 1 year as determined by the treating pulmonologist
- Any condition other than CLAD that will likely result in death in the next 1 year
- Any condition in the judgement of the principal investigator that would preclude participation in this study
- EKG with QTc interval \> 500 msec at screening
- Listed for repeat lung transplantation
Exclusion
Key Trial Info
Start Date :
April 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03473340
Start Date
April 27 2018
End Date
August 20 2021
Last Update
August 17 2022
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109