An Open Label Trial Evaluating Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
This is an open label, multicenter, safety and PK study comparing safety, efficacy, and
pharmacokinetic (PK) levels of Tacrolimus Inhalation Powder in lung transplant patients that
require reduced tacrolimus blood levels due to kidney toxicity.
Part A of the study will consist of a 12 week safety, efficacy, and PK study.
Part B of the study will be an optional safety extension following successful completion of
the 12 week safety, efficacy, and PK study. Patients would have the option to continue
Tacrolimus Inhalation Powder for up to 1 year, with a possibility to extend to 2 years
depending on the results from Part A.