At a glance
ClinicalIndex Comparison Record- ✓Age 3-65 years old
- ✓Kidney angiomyolipoma ≥2 cm on baseline MRI (or CT if MRI contraindicated)
- ✓No evidence of severe LAM (not on continuous oxygen)
- ✓Diagnosis of TSC or LAM confirmed by appropriate criteria
- ✕Unstable seizures in the 60 days prior to study entry
- ✕Significant bleed from kidney angiomyolipoma requiring transfusion or causing shock in the 30 days prior to study entry
- ✕Severe LAM defined as dependent on continuous supplemental oxygen
- ✕Evidence for accelerating renal dysfunction or acute renal failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients
In Brief
A Phase 2 clinical trial evaluating Rapamycin for Nonmalignant Neoplasm and 3 related conditions. Completed, enrolled 36 participants across 7 sites.
Detailed Summary
This research study is evaluating a drug called rapamycin as a possible treatment for the lumps (or tumors) that form in the kidneys, called angiomyolipomas, in people who have either TSC or LAM. Kidney angiomyolipomas are tumors that are made up of blood vessels, muscle and fat. Rapamycin has been approved to treat other diseases, but it is investigational for treating kidney angiomyolipomas. Investigational means that it is being as a possible treatment for kidney angiomyolipomas but is not currently approved by the U.S. Food and Drug Administration (FDA) for treating this disease.