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A Study to determine Pharmacokinetics of children receiving Modigraf (Tacrolimus granules) following solid organ transplantation

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.
NCT01371331

Astellas Study ID

The unique identification code given by the study sponsor.

F506-CL-0403

EudraCT ID

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

2009-012258-19

Follow Trial

Condition

Kidney Transplants, Heart Transplants, Liver Transplants

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

0 years - 12 years

Sex

Female & Male

Product

N/A

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

Jun 2011 - Feb 2015

Masking

None (Open Label)

Enrollment number

52

A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus granules) in de novo Paediatric Allograft Recipients

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 11

London, United Kingdom, WC1N3JH

Site 30

Heidelberg, Germany, 69120

Site: 61

Paris Cedex, France, 75935

Site: 41

Leuven, Belgium, 3000

Site: 60

Bron Cedex, France, 69677

Site 22

Madrid, Spain, 28007

Site 50

Warsaw, Poland, 04-730

Site 21

Madrid, Spain, 28046

Site 31

Hannover, Germany, 30625

Site 40

Brussels, Belgium, 1200

Site 20

Madrid, Spain, 28046

Site 13

Manchester, United Kingdom, M13 9WL

Site 10

Birmingham, United Kingdom, B4 6NH

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