A long-term follow-up of adult kidney and liver transplant recipients

• Research type

  Research Study

• Full title

  A long-term follow-up of adult kidney and liver allograft recipients previously enrolled into a Tacrolimus (Advagraf) trial – A Multicentre Non-Interventional Post Authorization Study (PAS).

• IRAS ID

  149442

• Contact name

  Paolo Muiesan

• Contact email

  Paolo.Muiesan@uhb.nhs.uk

• Sponsor organisation

  Astellas Pharma Europe Ltd

• Research summary

  This is a five year long-term follow-up, non-interventional study.

  Centres that have participated, or are currently participating, in selected Astellas-sponsored “Advagraf“ clinical trials (feeder trials) will be contacted and requested to approach patients for enrolment into this long-term follow up study. The following will be considered to be feeder studies:
  o Diamond – PMR-EC-1106
  o Advance – PMR-EC-1211
  o Adhere- PMR-EC-1212
  o Any new selected Astellas-sponsored Advagraf trial

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  14/SC/0252

• Date of REC Opinion

  1 May 2014

• REC opinion

  Further Information Favourable Opinion