Complete steroid avoidance is effective and safe in children with renal transplants: a multicenter randomized trial with three-year follow-up
Autor: | Sarwal, MM, Ettenger, RB, Dharnidharka, V, Benfield, M, Mathias, R, Portale, A, McDonald, R, Harmon, W, Kershaw, D, Vehaskari, VM, Kamil, E, Baluarte, HJ, Warady, B, Tang, L, Liu, J, Li, L, Naesens, M, Sigdel, T, Waskerwitz, Janie, Salvatierra, O |
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Rok vydání: | 2012 |
Předmět: |
Adult
Male Kidney Disease Adolescent growth Clinical Trials and Supportive Activities Renal and urogenital kidney transplantation Medical and Health Sciences Young Adult Rare Diseases Clinical Research Humans Corticosteroids Child Preschool Pediatric Transplantation graft function Infant Evaluation of treatments and therapeutic interventions Organ Transplantation Newborn side effects 6.1 Pharmaceuticals Steroids Female Surgery 6.4 Surgery Immunosuppressive Agents Follow-Up Studies |
Zdroj: | American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, vol 12, iss 10 |
Popis: | 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. |
Databáze: | OpenAIRE |
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