The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.
The primary objective of this study is to determine the pharmacokinetics (PK) of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in paediatric subjects undergoing de novo allograft transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
52
oral
Site 40
Brussels, Belgium
Site: 60
Bron, France
Site 31
Hanover, Germany
Site 30
Heidelberg, Germany
Determine AUCtau (area under the plasma concentration-time curve for a dosing interval)
Time frame: on Day 1 and Day 7 (+/- 7 days)
Determine Cmax (maximum concentration)
Time frame: on Day 1 and Day 7 (+/- 7 days)
Determine tmax (time to attain Cmax)
Time frame: on Day 1 and Day 7 (+/- 7 days)
Determine Ctrough (plasma concentration at the end of a dosing interval)
Time frame: on Day 1 and Day 7 (+/- 7 days)
Rejection episodes
Time frame: 14 days
Patient survival
Time frame: 14 days
Graft survival
Time frame: 14 days
Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs
Time frame: 14 days
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Site 50
Warsaw, Poland
Site 22
Madrid, Spain
Site 20
Madrid, Spain
Site 21
Madrid, Spain
Site 10
Birmingham, United Kingdom
Site 13
Manchester, United Kingdom