Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

May 31, 2010

Study Completion Date

May 31, 2010

Conditions
Liver Failure
Interventions
DRUG

LCP -Tacro

"LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"

DRUG

Prograf

"Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"

Trial Locations (1)

33606

LifeLink Healthcare Institute, Tampa

All Listed Sponsors
collaborator

CTI Clinical Trial and Consulting Services

OTHER

collaborator

Aptuit

INDUSTRY

lead

Veloxis Pharmaceuticals

INDUSTRY