Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients

PHASE3CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

August 17, 2012

Primary Completion Date

October 3, 2016

Study Completion Date

September 24, 2018

Conditions
Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant
Interventions
DRUG

RAD001

Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant

DRUG

MMF

MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids

Trial Locations (31)

1082

Novartis Investigative Site, Budapest

10126

Novartis Investigative Site, Torino

13353

Novartis Investigative Site, Berlin

14186

Novartis Investigative Site, Stockholm

16147

Novartis Investigative Site, Genova

20246

Novartis Investigative Site, Hamburg

30625

Novartis Investigative Site, Hanover

35128

Novartis Investigative Site, Padua

40138

Novartis Investigative Site, Bologna

45147

Novartis Investigative Site, Essen

48149

Novartis Investigative Site, Münster

59000

Novartis Investigative Site, Lille

63110

Novartis Investigative Site, St Louis

69120

Novartis Investigative Site, Heidelberg

69677

Novartis Investigative Site, Bron

72076

Novartis Investigative Site, Tübingen

75015

Novartis Investigative Site, Paris

75019

Novartis Investigative Site, Paris

90095-1752

Novartis Investigative Site, Los Angeles

48109-0331

Novartis Investigative Site, Ann Arbor

S3000EPV

Novartis Investigative Site, Santa Fe

90020-090

Novartis Investigative Site, Porto Alegre

04038-002

Novartis Investigative Site, São Paulo

00165

Novartis Investigative Site, Roma

0424

Novartis Investigative Site, Oslo

04 730

Novartis Investigative Site, Warsaw

08950

Novartis Investigative Site, Esplugues de Llobregat

07070

Novartis Investigative Site, Antalya

WC1N 1EH

Novartis Investigative Site, London

M13 9WL

Novartis Investigative Site, Manchester

NG7 2UH

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY