Safe Renal Function In Long Term Heart Transplanted Patients

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy

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Detailed Description

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Conditions

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Kidney Diseases Heart Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Everolimus

Intervention Type DRUG

cyclosporine dose reduced of 50% after introduction of everolimus

Interventions

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Everolimus

cyclosporine dose reduced of 50% after introduction of everolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Heart Transplant patients with more than 1 year of follow-up
* Creatinine lower than 3.5 mg/dl
* GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)
* Cyclosporine in maintenance immunosuppressive therapy
* Patient must be able to sign an approve informed consent
* Prior History of acute rejection within the last 3 months
* Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used

Exclusion Criteria

* Patients who are recipients of multiple organ transplants
* Prior or current use of sirolimus or everolimus
* History of acute rejection within the last 6 months
* Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months
* Patient not able to attend all follow-up evaluations

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No