NCT02432833View on ClinicalTrials.gov

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

PHASE4CompletedINTERVENTIONAL
Enrollment

428

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

January 24, 2017

Study Completion Date

January 24, 2017

Conditions
End Stage Renal Disease
Interventions
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

Trial Locations (1)

43123

Chiesi farmaceutici Spa, Parma

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter