Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Angiomyolipoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sirolimus

plasma levels between 4 and 8

Intervention Type DRUG

Other Intervention Names

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Rapamune

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No