Study Details
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted from Prograf® to Advagraf®
Clinicaltrials.gov ID
Astellas Study ID
PMR-EC-1206
EudraCT ID
2010-020925-42
Condition
Intestine Transplants, Kidney Transplants, Lung Transplants, Liver Transplants, Heart Transplants
Phase
Phase 2
Age
5 years - 16 years
Sex
Female & Male
Product
tacrolimus
Type
Interventional
Trial Dates
May 2011 - May 2026
Masking
None (Open Label)
Enrollment number
81
A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted from a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up
Study summary
Study documents
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Locations
Site FR33
Paris Cedex 15, France, 75908
Site IT71
Rome, Italy, 165
Site AT11
Vienna, Austria, 1090
Site CZ42
Prague 5, Czech Republic, 150 06
Site FR32
Paris Cedex 15, France, 75743
Site IT75
Palermo, Italy, 90127
Site IT73
Padova, Italy, 35128
Site DE41
Heidelberg, Germany, 69120
Site FR35
BRON Cedex, France, 69677
Site GB62
Birmingham, United Kingdom, B4 6NH
Site BE21
Brussels, Belgium, 1020
Site GB64
London, United Kingdom, WC1 3JH
Site IT72
Rome, Italy, 00165
Site IT74
Bergamo, Italy, 24127
Site GB61
Manchester, United Kingdom, M27 4HA
Site FR31
Paris Cedex 15, France, 75743
Site PL52
Warsaw, Poland, 04-730
Site PL51
Warsaw, Poland, 04-730
Site BE22
Brussels, Belgium, 1200
Site FR34
Bron Cedex, France, 69677