58
Participants
Start Date
October 31, 2008
Primary Completion Date
May 31, 2010
Study Completion Date
May 31, 2010
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)"
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)"
LifeLink Healthcare Institute, Tampa
Lead Sponsor
Collaborators (2)
CTI Clinical Trial and Consulting Services
OTHER
Aptuit
INDUSTRY
Veloxis Pharmaceuticals
INDUSTRY