A Paediatric Renal Transplant Study

• Research type

  Research Study

• Full title

  A 12-month, multicentre, open label, randomized, controlled study to evaluate the efficacy, tolerability and safety of early introduction of everolimus, reduced CNI, and early steroid elimination compared to standard CNI, mycophenolate mofetil and steroid regimen in paediatric renal transplant recipients with a 24-month additional safety follow-up

• IRAS ID

  108979

• Contact name

  Martin Christian

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-024381-21

• ISRCTN Number

  N/A

• Research summary

  The purpose of this study is to determine whether the use of everolimus combined with low dose tacrolimus is efficacious and safe and helps reduce the use of steroids in paediatric renal tranplant patients. An additional purpose of the study is to assess the effect of the combination of everolimus and tacrolimus on renal function. This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  12/EM/0400

• Date of REC Opinion

  27 Dec 2012

• REC opinion

  Further Information Favourable Opinion