Complete Steroid Avoidance Is Effective and Safe in Children With Renal Transplants: A Multicenter Randomized Trial with Three-Year Follow-Up.
Sarwal MM, Ettenger R, et al.American Journal of Transplantation, 12(10): 2719-2729. 2012.
Aims
To determine whether complete steroid avoidance is safe and effective in paediatric 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
The primary efficacy endpoint was the linear growth evaluated by standardized height Z-scores at 1 year. The primary safety endpoint was the rate of biopsy proven acute rejection at 12 months. Secondary endpoints included patient and graft survival, incidence of delayed graft function, acute rejection, renal function, incidence of hyperlipidemia, hypertension, anemia, leucopenia, infectious complications, surgical complications, incidence and duration of re-hospitalizations, incidence of biopsy proven post-transplant lymphoproliferative disease and incidence of post-transplant diabetes mellitu
Follow-up
3 years
CET Conclusions
In this multicenter randomised trial, paediatric recipients of a renal transplant were randomised to receive a steroid free or a steroid based immunosuppressive regimen, the concomitant immunosuppression being tacrolimus, mycophenolate and daclizumab. The follow-up was for 3 years. There was no significant difference in the standardised height Z score although recipients under 5 years of age did show improved growth with a steroid free regimen. There was no difference in biopsy proven acute rejection or patient survival but there was a significantly lower systolic blood pressure and cholesterol levels in the steroid free group. Thus steroid avoidance was safe and effective in non sensitised children given a first kidney transplant.
Data analysis
Strict intention-to-treat analysis
Trial registration
NCT00141037 (ClinicalTrials.gov)