Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation

PHASE4CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Liver Transplantation
Interventions
DRUG

Basiliximab

Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4

DRUG

Tacrolimus

Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL

DRUG

Tacrolimus

Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL

DRUG

Mycophenolic Acid

Enteric coated mycophenolic acid 360-720 mg po bid

Trial Locations (1)

90095

Ronald Reagan UCLA Medical Center, Los Angeles

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

University of California, Los Angeles

OTHER