Clinical trial
Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS)
Name
MIDAS
Description
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.
Trial arms
Trial start
2015-03-01
Estimated PCD
2024-07-31
Trial end
2025-07-31
Status
Recruiting
Treatment
Sirolimus
Sirolimus treatment will be part of a participant's clinical care and will be managed by their physician.
Arms:
Sirolimus
Other names:
Rapamune, rapamycin
Everolimus
Everolimus treatment will be part of a participant's clinical care and will be managed by their physician.
Arms:
Everolimus
Other names:
Afinitor
Size
600
Primary endpoint
Long term safety of mTOR inhibitor treatment in LAM
2-5 years
Efficacy - FEV1 slope
2-5 years
Efficacy -10% reduction in FEV1
2-5 years
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Inability to attend at least one RLD Clinic visit per year
* Inability to give informed consent
* Inability or unwillingness to perform pulmonary function testing
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}
Updated at
2024-05-16
1 organization
Organization
University of Cincinnati