NCT02432833

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	ENVARSUS®	Envarsus® tablets, once daily, oral formulation. Prolonged -release formulation of tacrolimus
DRUG	PROGRAF®	Prograf® hard capsules, twice daily, oral formulation
DRUG	ADVAGRAF®	Advagraf® prolonged-release hard capsules, once daily, oral formulation

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-01-24
• Completion: 2017-01-24
• First posted: 2015-05-04
• Last updated: 2018-04-13

Locations

1 site across 1 country: Italy