Study Comparing in Livertransplantation Recipients With Tacrolimus Alone Versus Tacrolimus&Sirolimus

PHASE4CompletedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

February 7, 2011

Primary Completion Date

May 20, 2021

Study Completion Date

May 20, 2021

Conditions
Liver Disease
Interventions
DRUG

Tacrolimus and Sirolimus

"Arm 1 once daily combination therapy of normal dosed extended-release tacrolimus and prednisone for 3 months and monotherapy once daily extended-release tacrolimus thereafter up to 3 years after liver transplantation.~Arm 2 once daily combination therapy of low doses sirolimus and extended-release tacrolimus and prednisone for 3 months and combination therapy of low dose sirolimus and extended-release tacrolimus thereafter for up to 3 years after liver transplantation Continue Advagraf (5-10 ng/ml) and 7.5 mg prednison; lower or discontinue steroids after day 180 at the discretion of the treating physician Conversion to sirolimus (3-5 ng/ml) and decrease Advagraf (3-5 ng/ml); 7.5 mg prednisone and lower or discontinue steroids after day 180 at the discretion of the treating physician"

DRUG

Tacrolimus

Patient received standard-dose of Tracrolimus Advagraf (5-10 ng/ml) and 7.5 mg prednison; lower or discontinue steroids after day 180 at the discretion of the treating physician

Trial Locations (3)

9713 GZ

UMCG, Groningen

2333 ZA

LUMC, Leiden

3015CE

Erasmus Medical Center, Rotterdam

Sponsors
All Listed Sponsors
lead

Foundation for Liver Research

OTHER