OPTION Version 1.0

• Research type

  Research Study

• Full title

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

• IRAS ID

  49472

• Contact name

  Deirdre Kelly

• Sponsor organisation

  Astellas Pharma Ltd.

• Eudract number

  2009-012258-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Tacrolimus has been on the market for more than 13 years as a capsule formulation and is one of the two cornerstone immunosuppressants following organ transplantation. Modigraf© has been developed specifically for patients unable to swallow capsules and takes the form of tacrolimus granules for suspension. This study was designed to test the way a child's body processes and uses up Modigraf (this is called pharmacokinetics or PK). Pharmacokinetic properties of a drug help determine the most suitable dose. Currently the amount of data available on the pharmacokinetics of Modigraf is limited. Therefore Astellas, the sponsoring company, were advised by the authorities to gather additional PK data on Modigraf when given to children. Patients meeting the inclusion / exclusion criteria for the study will be asked to provide additional blood samples for the PK testing on two occasions after their transplant. The first occasion will be the day that the patient starts to take tacrolimus granules and the second will be approximately one week later. This study will last for approximately 14 days for each patient. During the 14 days the study doctor will adjust the drug dose given to child to suit them best. These adjustments will be done based on drug blood levels, side effects experienced by the participant and on the condition of the transplanted organ. At the end of the study patients will be given the opportunity to enter a follow up study, where they will continue receiving study Modigraf for three months before switching to commercially available Modigraf or to study Prograf. This will depend on what treatment is most suitable for them as determined by the study doctor. Patients and their families will formally agree to participate in this study by signing informed consent (parent/guardian) and informed assent (children). Patients and their parents/guardians will be free to withdraw participation.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0013

• Date of REC Opinion

  21 Apr 2011

• REC opinion

  Further Information Favourable Opinion