44
Participants
Start Date
December 31, 2011
Primary Completion Date
August 31, 2012
Study Completion Date
July 31, 2015
Prograf
Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.
LCP-Tacro
LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
Clinical Investigative Site 009, Nashiville
Clinical Investigative Site 004, Lexington
Clinical Investigative Site 008, Minneapolis
Clinical Investigative Site 003, St Louis
Clinical Investigative Site 002, Oklahoma City
Clinical Investigative Site 012, Dallas
Clinical Investigative Site 007, Aurora
Clinical Investigative Site 006, Los Angeles
Clinical Investigative Site 1049, San Diego
Clinical Investigative Site 005, New Haven
Lead Sponsor
Veloxis Pharmaceuticals
INDUSTRY