Complete Steroid Avoidance Is Effective and Safe in Children With Renal Transplants: A Multicenter Randomized Trial With Three-Year Follow-Up

作者:Sarwal M M*; Ettenger R B; Dharnidharka V; Benfield M; Mathias R; Portale A; McDonald R; Harmon W; Kershaw D; Vehaskari V M; Kamil E; Baluarte H J; Warady B; Tang L; Liu J; Li L; Naesens M; Sigdel T; Waskerwitz J; Salvatierra O
来源:American Journal of Transplantation, 2012, 12(10): 2719-2729.
DOI:10.1111/j.1600-6143.2012.04145.x

摘要

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.

  • 出版日期2012-10