Safety and Durability of Sirolimus for Treatment of LAM
ConditionLymphangioleiomyomatosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Cincinnati
About this trial
The MIDAS study aims to follow male and female LAM patients who are currently taking, have previously failed or been intolerant of, or may (at some time in the future) take mTOR inhibitors (sirolimus or everolimus) as part of their clinical care. Adult female TSC patients may also enroll, with or without lung cysts.
Eligibility criteria
Qualifiers
Female or male, age 18 or over
Diagnosis of LAM based on ATS/JRS criteria
Signed and dated informed consent
On chronic therapy, newly treated or may be considered for therapy with mTOR inhibitors or previously intolerant of or having failed mTOR inhibitor therapy
Disqualifiers
Inability to attend at least one RLD Clinic visit per year
Inability to give informed consent
Inability or unwillingness to perform pulmonary function testing
Trial design
Treatments tested in this trial
- Sirolimus
- Everolimus
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Cincinnati
Lead sponsor
Rare Diseases Clinical Research Network
Collaborator
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
The LAM Foundation
Collaborator
Source ClinicalTrials.gov