Conditions: Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant
Keywords: Paediatric kidney transplantation Early MMF to everolimus conversion Composite efficacy (biopsy-proven acute rejection, graft loss or death) Renal function
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant arm 2: MMF continuation (in combination with tacrolimus and standard dose steroids)

Interventions: intervention 1: RAD001 intervention 2: MMF
Intervention descriptions: intervention 1: Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant intervention 2: MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids

Protocol document: