Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
17
Unnamed facility
Vienna, Austria
Unnamed facility
Leuven, Belgium
Unnamed facility
Paris, France
Unnamed facility
Milan, Italy
Unnamed facility
determine steady state systemic exposure (AUC 0-24h)
Time frame: Day 1, Day 3, Day 7 and Day 42
determine Cmax (maximum concentration)
Time frame: Day 1, Day 3, Day 7 and Day 42
determine tmax (time to attain Cmax)
Time frame: Day 1, Day 3, Day 7 and Day 42
determine C24 (concentration prior to next morning dose)
Time frame: Day 1, Day 3, Day 7 and Day 42
describe rejection episodes
Time frame: up to 58 weeks
describe subject survival
Time frame: up to 58 weeks
describe graft survival
Time frame: up to 58 weeks
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Padua, Italy
Unnamed facility
Taipei, Taiwan
Unnamed facility
London, United Kingdom
Unnamed facility
Manchester, United Kingdom