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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

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01614665

Astellas Study ID

The unique identification code given by the study sponsor.

PMR-EC-1207

EudraCT ID

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

2011-000078-80

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Condition

Heart Transplants, Kidney Transplants, Liver 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

N/A - 15 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

Apr 2012 - Apr 2021

Masking

None (Open Label)

Enrollment number

44

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

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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Would you like more information about clinical trial sites that are recruiting participants for 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? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

Site PL72

Warsaw, Poland, 04-736

Site GB41

London, United Kingdom, WC1N3JH

Site GB44

London, United Kingdom, SE5 9RS

Site AT11

Vienna, Austria, 1090

Site PL71

Warsaw, Poland, 04-730

Site PL73

Zabrze, Poland, 41-800

Site GB43

Birmingham, United Kingdom, B4 6NH

Site FR33

Bron Cedex, France, 69677

Site IT52

Rome, Italy, 00165

Site GB45

London, United Kingdom, WC1 3JH

Site IT51

Bergamo, Italy, 24127

Site GB42

Manchester, United Kingdom, M13 9WL

Site FR32

Paris Cedex 15, France

Site BE22

Leuven, Belgium, 3000

Site GB46

Liverpool, United Kingdom, L12 2AP

Site CZ61

Prague 5, Czech Republic, 150 06

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