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Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients — STEADY  

End Stage Renal Disease Clinical Trial

Official title:
Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

Clinical Trial Summary

The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months following de novo renal transplantation in a real-life setting in different European Countries.

Clinical Trial Description

This is a Multicentre, Open label, Randomized, Two-arm, parallel-group study to assess efficacy and safety of Envarsus® compared with tacrolimus used as per current clinical practice in the initial maintenance setting in de novo kidney transplant patients. The study will be conducted in approximately 10 european countries. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02432833
Study type Interventional
Source Chiesi Farmaceutici S.p.A.
Contact
Status Completed
Phase Phase 4
Start date May 2015
Completion date January 24, 2017
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