Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

Phase 4

Completed

• Conditions: Angiomyolipoma

• Registration Number: NCT01217125
• Lead Sponsor: Fundacio Puigvert

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Angiomyolipoma volume	2 years	Measured by MRI

Secondary Outcome Measures

Name	Time	Method
skin lesions, AML complications,	2 years	Evaluate skin lesions Collect event realted to AML