Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

Fundacio Puigvert18 enrolled

Overview

The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Angiomyolipoma

Interventions

SirolimusDRUG

plasma levels between 4 and 8

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Angiomyolipoma volume

Measured by MRI

Time frame: 2 years

Secondary Outcomes

skin lesions, AML complications,

Evaluate skin lesions Collect event realted to AML

Time frame: 2 years

Data from ClinicalTrials.gov

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