PROGRESSION Version 1.0

• Research type

  Research Study

• Full title

  A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in Paediatric Solid Allograft Recipients.

• IRAS ID

  52873

• Contact name

  Deirdre Kelly

• Sponsor organisation

  Astellas Pharma Ltd.

• Eudract number

  2009-012259-21

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Tacrolimus has been marketed in over 90 countries with an estimated 2.1 million patients-years (children and adults) of exposure. There are a number of formulations of tacrolimus that have been developed; Prograf© is a taken twice daily while Advagraf© is taken once daily (taken by adults only) both of which are capsules and taken by mouth. Modigraf© has been developed as an alternative treatment to Prograf© for patients unable to swallow capsules and this takes the form of tacrolimus granules which can be made into a suspension. The PROGRESSION study is an extension study of the OPTION trial (F506-CL-403). Patients and their Parent(s)/legal guardian(s) will be told of PROGRESSION when they are enrolled into OPTION. If the physician deems the subject will directly benefit from further treatment of Modigraf© they may have the opportunity to continue their treatment within the PROGRESSION study provided the subject and their parent(s)/legal guardian(s) are willing to take part. PROGRESSION is divided into two parts. Part A and Part B. The purpose of part A is to see how well Modigraf© works in children who are having an organ transplant. The purpose of Part B is to see what happens to blood concentration levels of tacrolimus when the subject is converted from Modigraf© to Prograf©. Children will only be offered participation in Part B once they are able to swallow Prograf capsules. For some children there may be a gap between Part A and Part B where they will take commerical Modigraf. The information that is obtained from this study may improve the treatment of children who undergo organ transplantation.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0014

• Date of REC Opinion

  21 Apr 2011

• REC opinion

  Further Information Favourable Opinion