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

Recruitment complete
The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01294020

Astellas Study ID

The unique identification code given by the study sponsor.

PMR-EC-1206

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2010-020925-42

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Condition

Intestine Transplants, Kidney Transplants, Lung Transplants, Liver Transplants, Heart Transplants

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

5 years - 16 years

Sex

Female & Male

Product

tacrolimus

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

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

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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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

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