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COMPLETED
NCT01294020
PHASE2

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®

Sponsor: Astellas Pharma Europe Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

Tacrolimus

Oral capsule

DRUG

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