Corticosteroid-Free Kidney Transplantation Improves Growth: 2-Year Follow-up of the TWIST Randomized Controlled Trial.

Nicholas J A Webb, Sarah E Douglas, Azita Rajai, Stephen A Roberts, Ryszard Grenda, Stephen D Marks, Alan R Watson, Maggie Fitzpatrick, Karel Vondrak, Heather Maxwell, Jeno Jaray, Rita Van Damme-Lombaerts, David V Milford, Nathalie Godefroid, Pierre Cochat, Milos Ognjanovic, Luisa Murer, Mignon McCulloch, Burkhard Tönshoff

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BACKGROUND: Corticosteroid withdrawal (CW) after pediatric kidney transplantation potentially improves growth while avoiding metabolic and other adverse effects. 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 corticosteroid continuation 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.
Original languageEnglish
Publication statusPublished - 23 Dec 2014


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