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Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Sponsor: Astellas Pharma Europe Ltd.
Summary
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy. Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.
Official title: 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
Key Details
Gender
All
Age Range
5 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
81
Start Date
2011-05-25
Completion Date
2025-11-03
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Tacrolimus
Oral capsule
Tacrolimus prolonged release
Oral capsule
Locations (16)
Site BE21
Brussels, Belgium
Site BE22
Brussels, Belgium
Site CZ42
Prague, Czechia
Site FR34
Bron, France
Site FR35
Bron, France
Site FR31
Paris, France
Site FR32
Paris, France
Site FR33
Paris, France
Site DE41
Heidelberg, Germany
Site IT74
Bergamo, Italy
Site IT75
Palermo, Italy
Site PL51
Warsaw, Poland
Site PL52
Warsaw, Poland
Site GB62
Birmingham, United Kingdom
Site GB64
London, United Kingdom
Site GB61
Manchester, United Kingdom