Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-07-31

Brief Summary

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To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.

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Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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everolimus-based immunosuppression

immunosuppression with everolimus, prednisone and mycophenolate

Group Type EXPERIMENTAL

everolimus

Intervention Type DRUG

comparison of everolimus-based and CNI-based immunosuppression

standard immunosuppression

immunosuppression with tacrolimus, prednisone and mycophenolate

Group Type ACTIVE_COMPARATOR

everolimus

Intervention Type DRUG

comparison of everolimus-based and CNI-based immunosuppression

Interventions

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everolimus

comparison of everolimus-based and CNI-based immunosuppression

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 18-75 yr
* Willingness to provide written informed consent
* Ability to understand the study procedures

Exclusion Criteria

* Life expectancy \< 3 months
* Claustrophobia
* Allergy to iodinated contrast
* Treatment incompliance
* Pregnancy
* Highly HLA-sensitized patients
* Severe dyslipidemia or proteinuria
* Severe leucopenia or thrombocytopenia
* GFR \< 30 ml/min

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No