Status:
COMPLETED
Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis
Lead Sponsor:
Fundacio Puigvert
Collaborating Sponsors:
Ministry of Health, Spain
Conditions:
Angiomyolipoma
Eligibility:
All Genders
10+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.
Eligibility Criteria
Inclusion
- Diagnosis of tuberousclerosis Angiomyolipoma \>2cm age\>10 years
Exclusion
- Creatinine \>4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit\<27% Thrombocytopenia (\<100.000/mm3) Leukopenia (\<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l or hypertriglyceridemia fasten(\>4.6 mmol/l) non controlled with drugs malignancy in the previous 2 years allergy to macrolides
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01217125
Start Date
October 1 2008
End Date
May 1 2011
Last Update
March 8 2012
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