Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

Novartis Pharmaceuticals

Overview

The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients. Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Kidney Transplantation

Interventions

EverolimusDRUG

Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * Primary or secondary renal transplantation in the past 12-36 months. * Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids. * Moderately impaired renal function Exclusion criteria * Multi-organ recipients or previous transplantation with an organ other than a kidney. * Acute rejection episodes in the last 6 months. Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Novartis Investigative Site

Zurich, Switzerland

Outcomes

Primary Outcomes

Routine safety laboratory

Time frame: At baseline

Routine safety laboratory

Time frame: Week 1

Routine safety laboratory

Time frame: Month 1

Routine safety laboratory

Time frame: Week 2

Routine safety laboratory

Time frame: Week 3

Routine safety laboratory

Time frame: Month 2

Routine safety laboratory

Time frame: Month 4

Routine safety laboratory

Time frame: Month 6

Secondary Outcomes

renal function

Time frame: At baseline

renal function

Time frame: Weeks 1, 2 and 3

renal function

Time frame: Months 1, 2, 4 and 6

Data from ClinicalTrials.gov

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