59
Participants
Start Date
November 30, 2007
Primary Completion Date
June 30, 2008
Study Completion Date
June 30, 2008
LCP Tacro
"In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8.~LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in the morning, with an interval of 24 ± 1 h between doses.~Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL."
Prograf
Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day 0 through Day 7 to maintain target trough levels of 5-12 ng/mL.
University of Cincinnati, Cincinnati
Lead Sponsor
Collaborators (1)
CTI Clinical Trial and Consulting Services
OTHER
Veloxis Pharmaceuticals
INDUSTRY