BACKGROUND: Corticosteroid withdrawal (CW) after pediatric kidney transplantation potentially improves growth while avoiding metabolic and other adverse events. We have recently reported the results of a 196 subject randomized controlled trial comparing early CW (tacrolimus, mycophenolate mofetil (MMF), daclizumab, and corticosteroids until day 4) with tacrolimus, MMF, and corticosteroid continuation (CC). At 6 months, CW subjects showed better growth with no adverse impact on acute rejection or graft survival (Am J Transplant 2010; 10: 828-836). This 2-year investigator-driven follow-up study aimed to determine whether improved growth persisted in the longer term. METHODS: Data regarding growth, graft outcomes and adverse events were collected at 1 year (113 patients) and 2 years (106 patients) after transplantation. The primary endpoint, longitudinal growth calculated as delta height standard deviation score, was analyzed using a mixed model repeated measures model. RESULTS: Corticosteroid withdrawal subjects grew better at 1 year (difference in adjusted mean change, 0.25; 95% confidence interval, 0.10, 0.40; P = 0.001). At 2 years, growth remained numerically better in CW subjects (0.20 (-0.01, 0.41); P = 0.06), and significantly better in prepubertal subjects (0.50 (0.16, 0.84); P = 0.004). Bacterial and viral infection was significantly more common in CW subjects at 1 year only. Corticosteroid withdrawal and CC subjects received similar exposure to both tacrolimus and MMF at 1 and 2 years. No significant difference in patient or graft survival, rejection, estimated glomerular filtration rate, or other adverse events was detected. CONCLUSION: Early CW effectively and safely improves growth up to 2 years after transplantation, particularly in prepubertal children.

Department of Paediatric Nephrology Royal Manchester Children's Hospital Central Manchester University Hospitals NHS Foundation Trust Manchester Academic Health Science Centre Manchester United Kingdom 2 Institute of Human Development Faculty of Medical and Human Sciences University of Manchester Manchester United Kingdom 3 Research and Innovation Department Central Manchester University Hospitals NHS Foundation Trust Manchester Academic Health Science Centre Manchester United Kingdom 4 Centre for Biostatistics University of Manchester Manchester United Kingdom 5 Department of Nephrology Kidney Transplantation and Hypertension Children's Memorial Health Institute Warsaw Poland 6 Department of Paediatric Nephrology Great Ormond Street Hospital London United Kingdom 7 Department of Paediatric Nephrology Nottingham University Hospitals Nottingham United Kingdom 8 Department of Paediatric Nephrology Leeds General Infirmary Leeds United Kingdom 9 Department of Paediatric Nephrology University Hospital Motol Prague Czech Republic 10 Department of Paediatric Nephrology Royal Hospital for Sick Children Glasgow United Kingdom 11 Department of Paediatric Nephrology Semmelweis University of Medicine Budapest Hungary 12 Department of Pediatric Nephrology Universitair Ziekenhuis KU Leuven Belgium 13 Department of Paediatric Nephrology Birmingham Children's Hospital Birmingham United Kingdom 14 Department of Pediatrics Cliniques Universitaires Saint Luc Université catholique de Louvain Medical School Brussels Belgium 15 Department of Pediatric Nephrology Hopital Femme Mere Enfant Lyon France 16 Department of Paediatric Nephrology Royal Victoria Infirmary Newcastle upon Tyne United Kingdom 17 Department of Paediatrics Azienda Ospedaliera di Padova Padova Italy 18 Department of Pediatric Nephrology Red Cross Children's Hospital Cape Town South Africa 19 Department of Paediatrics 1 University Children's

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Efficacy and safety of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus

Steroid withdrawal improves blood pressure control and nocturnal dipping in pediatric renal transplant recipients: analysis of a prospective, randomized, controlled trial