Corticosteroid-free Kidney Transplantation Improves Growth: 2-Year Follow-up of the TWIST Randomized Controlled Trial. Issue 6 (June 2015)

• Record Type: Journal Article
• Authors: Webb, Nicholas J. A.; Douglas, Sarah E.; Rajai, Azita; Roberts, Stephen A.; Grenda, Ryszard; Marks, Stephen D.; Watson, Alan R.; Fitzpatrick, Maggie; Vondrak, Karel; Maxwell, Heather; Jaray, Jeno; Van Damme-Lombaerts, Rita; Milford, David V.; Godefroid, Nathalie; Cochat, Pierre; Ognjanovic, Milos; Murer, Luisa; McCulloch, Mignon; Tönshoff, Burkhard
• Is Part Of: Transplantation. Volume 99:Issue 6(2015)
• Publication Date: 2015-06
• Subjects: Transplantation of organs, tissues, etc -- Periodicals; Transplantation immunology -- Periodicals; 617.95
• DOI: 10.1097/TP.0000000000000498
• Languages: English
• ISSNs: 0041-1337

Abstract

Abstract : 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. Abstract : This prospective, randomized trial of early glucocorticoid withdrawal in pediatric renal allograt recipients shows both early and sustained benefits in growth for up to 2 years after transplantation, without an adverse effect on rejection, infection, GFR, or survivals.