Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up
M M Sarwal, R B Ettenger, V Dharnidharka, M Benfield, R Mathias, A Portale, R McDonald, W Harmon, D Kershaw, V M Vehaskari, E Kamil, H J Baluarte, B Warady, L Tang, J Liu, L Li, M Naesens, T Sigdel, Janie Waskerwitz, O Salvatierra, M M Sarwal, R B Ettenger, V Dharnidharka, M Benfield, R Mathias, A Portale, R McDonald, W Harmon, D Kershaw, V M Vehaskari, E Kamil, H J Baluarte, B Warady, L Tang, J Liu, L Li, M Naesens, T Sigdel, Janie Waskerwitz, O Salvatierra
Abstract
To determine whether steroid avoidance in pediatric kidney transplantation is safe and efficacious, a randomized, multicenter trial was performed in 12 pediatric kidney transplant centers. One hundred thirty children receiving primary kidney transplants were randomized to steroid-free (SF) or steroid-based (SB) immunosuppression, with concomitant tacrolimus, mycophenolate and standard dose daclizumab (SB group) or extended dose daclizumab (SF group). Follow-up was 3 years posttransplant. Standardized height Z-score change after 3 years follow-up was -0.99 ± 2.20 in SF versus -0.93 ± 1.11 in SB; p = 0.825. In subgroup analysis, recipients under 5 years of age showed improved linear growth with SF compared to SB treatment (change in standardized height Z-score at 3 years -0.43 ± 1.15 vs. -1.07 ± 1.14; p = 0.019). There were no differences in the rates of biopsy-proven acute rejection at 3 years after transplantation (16.7% in SF vs. 17.1% in SB; p = 0.94). Patient survival was 100% in both arms; graft survival was 95% in the SF and 90% in the SB arms (p = 0.30) at 3 years follow-up. Over the 3 year follow-up period, the SF group showed lower systolic BP (p = 0.017) and lower cholesterol levels (p = 0.034). In conclusion, complete steroid avoidance is safe and effective in unsensitized children receiving primary kidney transplants.
Trial registration: ClinicalTrials.gov NCT00141037.
Conflict of interest statement
DISCLOSURE
None of the authors have any conflict of interest to declare in relation to this study.
© Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.
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Source: PubMed