Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Novartis Pharmaceuticals

Overview

In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in maintenance heart transplant recipients with impaired renal function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Heart Transplantation

Interventions

EverolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Recipients of primary heart transplant * Reduced renal function (serum creatinine \> 1.7 ng/mL over 2 months or more) at 6 months or more after heart transplantation * Patients with current immunosuppressive therapy consisting of cyclosporine microemulsion and mycophenolate mofetil Exclusion Criteria: * Patients who are recipients of multiple organ transplants * Patients who have previously received an organ transplant * Patients with serum creatinine \> 3.5 mg/dl Other protocol-defined exclusion criteria may apply.

Locations (1)

Novartis Investigational Site

Various Cities, Germany

Data from ClinicalTrials.gov

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