Subclinical Inflammation and Chronic Renal Allograft Injury in a Randomized Trial on Steroid Avoidance in Pediatric Kidney Transplantation.
Naesens M, Salvatierra O, et al.American Journal of Transplantation [record in progress].
Aims
To evaluate the effect of steroid avoidance on allograft histology in pediatric kidney transplantation.
Interventions
Complete steroid avoidance with prolonged daclizumab induction versus steroid treatment plus standard daclizumab. All patients received tacrolimus and mycophenolate mofetil concomitant immunosuppression therapy.
Participants
130 paediatric renal transplant recipients.
Outcomes
1-year and 3-year cumulative incidence of acute T cell-mediated rejection, borderline changes in patients without T cell-mediated rejection, acute T cell-mediated rejection or borderline changes, acute antibody-mediated rejection and chronic antibody-mediated rejection evaluated by renal allograft biopsies at the time of graft dysfunction; prevalence of subclinical acute T cell-mediated rejection, subclinical borderline changes, acute antibody-mediated rejection and chronic antibody-mediated rejection evaluated by per protocol biopsies at transplantation, 6, 12 and 24 months post-transplantat
Follow-up
3 years
CET Conclusions
In this 3-year follow up of the multicenter trial in paediatric kidney transplantation described above the histology in steroid free versus a steroid based immunosuppressive regimen was examined in protocol and indication biopsies. There was no difference in the incidence of clinical acute rejection in that time, nor in the incidence of antibody mediated rejection. However there was a significant increase in chronic histological damage with time, but there was no difference between the steroid free and the steroid based groups. Chronic histological injury was more related to an increasing donor age and a smaller recipient size.
Data analysis
Strict intention-to-treat analysis
Quality notes
This paper reported the same trial of the publication: Sarwal MM, Ettenger R, et al. Complete Steroid Avoidance Is Effective and Safe in Children With Renal Transplants: A Multicenter Randomized Trial with Three-Year Follow-Up. American Journal of Transplantation [record in progress]. The methodological quality assessment was based on the article by Sarwal et al.
Trial registration
NCT00141037 (ClinicalTrials.gov)