Shift to Everolimus (RAD) Kidney Sparing Study

Phase 4TerminatedNCT00420537

University of Bologna34 enrolled

Overview

The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Kidney Dysfunction Heart Transplantation

Interventions

cyclosporineDRUG

cyclosporine trough levels between 100 and 150

cyclosporineDRUG

cyclosporine trough levels between 40 and 90 ng/ml

Mycophenolate mofetilDRUG

mycophenolate with low doses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Heart Transplant with 1 to 4 years of follow-up * GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula) Exclusion Criteria: * Acute rejection in the previous 6 months * Contraindications to statin therapy * Ongoing infection * Ongoing heart failure * Myocardial infarction or myocardial revascularization after transplant * Malignancy

Locations (1)

Policlinico S.Orsola-Malpighi

Bologna, Italy

Outcomes

Primary Outcomes

Calculated GFR

Time frame: One year after randomization

Data from ClinicalTrials.gov

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