13
Participants
Start Date
December 31, 2007
Primary Completion Date
April 30, 2009
Study Completion Date
July 31, 2009
LCP-Tacro (tacrolimus)
LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
Azathioprine
Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
Mount Sinai Medical Center, New York
Virginia Commonwealth University, Richmond
Mayo Clinic - Jacksonville, Jacksonville
University of Minnesota, Minneapolis
Mayo Clinic, Rochester
Northwestern University, Chicago
St. Luke's Advanced Liver Therapies, Houston
Mayo Clinic - Phoenix, Phoenix
Heritage Medical Research Clinic, Calgary
Zeildler Ledcor Centre, Edmonton
John Buhler Research Centre, University of Manitoba Health Sciences Centre, Winnipeg
Queen Elizabeth II Health Sciences Centre, Halifax
Lead Sponsor
Veloxis Pharmaceuticals
INDUSTRY