Macitentan in the Treatment of Organ Rejection After Lung Transplantation
Status:
Withdrawn
Trial end date:
2019-09-19
Target enrollment:
Participant gender:
Summary
Potential therapy with MACITENTAN in the treatment of Chronic Lung Allograft Dysfunction
(CLAD) after Lung Transplantation. Pilot Study, Double-blind, "ADD-ON Therapy" with
MACITENTAN to "usual standard of care immunosuppressive therapies" after lung transplantation
for established BOS Stages I or II versus a "matched control group" who receive "usual
standard of care immunosuppressive therapies" alone, results in a decrease in the Primary
Endpoint: "rate of decline" in "Forced Expiratory Volume-1 sec (FEV1) versus time" while
Secondary Endpoints including: differences in Six minute walk distance (6MWD), BORG Score,
corrected single-breath diffusing capacity (DCO corrected) at time intervals of 1, 3, 6
months on therapy. Specific biomarkers for BOS, including inflammatory chemokines, which are
routinely collected in the context of post-transplant "surveillance" will be analyzed.
Chemokines which our group has previously described in the pathogenesis of the continuum of
"acute-to-chronic lung allograft rejection", have included both C-C (CCL2, CCL5) and CXC
(CXCL9, CXCL10, CXCL11) chemokines as determined in bronchial-alveolar lavage (BAL).