A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and effective they are over a longer period of time.
This study is for children less than 16 years old. No minimum age has been set, however, to be included in this study participants must able to swallow the medication capsules intact.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Phase II, Parallel Group, Randomized, Multicentre, Open Label Study to Compare the Pharmacokinetics of Tacrolimus in De Novo Pediatric Allograft Recipients Treated With an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up|
- Part A: Determine steady state systemic exposure (AUC0-24h) [ Time Frame: Day 1, Day 7 and Day 28 ] [ Designated as safety issue: No ]
- Part A & B: Assessment of safety through the evaluation of adverse events, laboratory parameters and vital signs [ Time Frame: Up to 1 year (End of study) ] [ Designated as safety issue: Yes ]
- Part A: Determine Cmax (maximum concentration) [ Time Frame: Day 1, Day 7 and Day 28 ] [ Designated as safety issue: No ]
- Part A: Determine Tmax (time to attain Cmax) [ Time Frame: Day 1, Day 7 and Day 28 ] [ Designated as safety issue: No ]
- Part A: Determine C24 (concentration prior to morning dose) [ Time Frame: Day 1, Day 7 and Day 28 ] [ Designated as safety issue: No ]
- Part A & B: Rejection episodes [ Time Frame: Up to 1 year (End of study) ] [ Designated as safety issue: No ]
- Part A & B: Subject and graft survival [ Time Frame: Up to 1 year (End of study) ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Prograf®||
Subjects undergoing primary heart, kidney or liver transplantation and meeting the Inclusion Criteria and complying with the Exclusion Criteria prior to initiation of tacrolimus therapy will be enrolled.
Subjects will be randomized to treatment with either Advagraf® or Prograf®. The randomization will be on a 1:1 basis stratified by organ and centre.
The study is divided in to two parts:
Part A: The initial pharmacokinetic part of the study.
Part B: A long term follow-up of one year. The main objective of Part A of the study is to collect PK data following administration of Advagraf® and Prograf® in de novo pediatric allograft recipients. Part B allows comparison of the safety and efficacy profiles of Advagraf® vs. Prograf® for longer term (52 weeks) post allograft transplantation.
Part C: Continuation of long-term follow-up (from Day 365 onwards). Patients who have completed Part B and to whom continued treatment with Advagraf® is not currently available, will be offered participation in a continuation of long-term follow-up Part C. Part C will continue until Advagraf® becomes available to these patients or these patients' discontinuation, whichever is the earliest.
This applies to patients in the following countries: Czech Republic, Italy and Poland only.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614665
|Contact: Medical Affairs Europe||+ 44 1784 419400||Astellas.firstname.lastname@example.org|
|Vienna, Austria, 1090|
|Leuven, Belgium, 3000|
|Prague 5, Czech Republic, 150 06|
|Paris Cedex 15, Necker, France|
|Bron Cedex, France, 69677|
|Bergamo, Italy, 24127|
|Rome, Italy, 00165|
|Warsaw, Poland, 04-730|
|Warsaw, Poland, 04-736|
|Zabrze, Poland, 41-800|
|Birmingham, United Kingdom, B4 6NH|
|Liverpool, United Kingdom, L12 2AP|
|London, United Kingdom, SE5 9RS|
|London, United Kingdom, WC1 3JH|
|London, United Kingdom, WC1N3JH|
|Manchester, United Kingdom, M13 9WL|
|Study Director:||Clinical Study Manager||Astellas Pharma Europe Ltd.|