Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation

Phase 4TerminatedNCT01276834

Dianet Dialysis Centers13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

everolimusDRUG

comparison of everolimus-based and CNI-based immunosuppression

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

change in coronary artery calcification score

Comparison in a randomised way the effect of a calcineurin-based immunosuppressive regimen with an mTOR-based regimen on progression of coronary calcification on renal transplant patients. The results of this study will provide more insight in protection against cardiovascular disease in renal transplant patients.

Time frame: 3 years

Data from ClinicalTrials.gov

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