Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)
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.
Timeline
- Start
- 2018-04-27
- Primary completion
- 2021-07-23
- Completion
- 2021-08-20
Outcome
Missed primary endpoint
Stopped (Enrollment): “Slow and delayed recruitment due in part to COVID, led to a decision to end funding and terminate the trial.”
registry analysis (superiority test); Pirfenidone Capsule vs Placebo Capsule; p = 0.17697507; t-test, 2 sided NCT03473340 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pirfenidone | Small molecule | 801 mg | Oral |