Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant Clinical Trial
Official title:
A 12-month, Multicenter, 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.
The purpose of this study is to determine if everolimus combined with reduced exposure CNI
(TAC) is efficacious and safe and will support corticosteroid elimination compared to a
standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation.
An additional purpose of the study is to assess the effect of the combination of EVR and
reduced exposure CNI (TAC) 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 10, 2010, and
is intended to support the indication of everolimus in the prevention of acute rejection in
paediatric recipients of a renal transplant.
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